International Regulatory Compliance

Notified Bodies And CE Marking – Potential Legal Issues In US Lawsuits #4

 

Continuation 

In this blog I want to focus specifically on the Silicon Breast Implant controversy involving the breast implant manufacturer Poly Implants Prothèses (PIP) and the EU regulatory structure for CE Marking medical devices. In my preceding three blogs times I have noted several problems concerning medical device product quality. In the first blog I quoted former European Commission Vice President Martin Bangemen.

In his preface to The Guide to the Implementation of Community Harmonization Directives Based on the New Approach and the Global Approach, Brussels, 1995, Vice President of the European Commission, Martin Bangeman stated the following:

The novelty of this new approach resides essentially in the use of community technical rules of “quality instruments” such as European Standardization and conformity assessment procedures (testing, product certification, certification of manufacturers’ quality control procedures, accreditation, etc.). These instruments, drawn up on the basis of consensus of all the economic partners involved, enable manufacturers to affix the CE marking--a real “technical passport”--to their industrial products, which must conform to these community directives.

The idea of separating compliance into product quality and process quality seemed like a good and workable idea at the time. However, looking backward from 2012, the growth of the EU to 27 Member States and a population of 500 million people, the separation into product quality and process quality needs to be readdressed. 

EU Medical Device Oversight Structure 

Medical Device Product Quality

In the EU, device regulations are not conducted by member state Competent National Authorities, instead they are conducted by one of the 70 approved for-profit Notified Bodies that must be approved by one of the EU’s 27 Competent National Authorities (called competent bodies) to act as a Notified Body for one of the three Medical Devices Directives. Consequently, member states are removed from direct legal oversight and legal enforcement of medical device regulations and hampered in their ability to oversee medical device failures.

To reason that 70 for-profit Notified Bodies can employ 70, 60 or 50 device experts for hundreds of different medical devices in multiple offices around the world isn’t credible. Consequently, the dearth of available device experts will continue to negatively affect the quality of medical devices being manufactured. While it might be reasoned that large established Notified Bodies could field multiple device experts, even they struggle to provide adequate product safety oversight. The Notified Body chosen by Poly Implants Prothèses (PIP) was TUV Rheinland, a well-established and respected Notified Body. The inspection however, occurred with advanced warning at the PIP plant in China, which raises a whole set of questions.

I have talked with principals at several Notified Bodies who privately admit that it is difficult for them to hire and retain qualified medical device experts. The number of silicon breast medical device manufacturers approved by the EU Notified Body structure has been estimated in various newspaper accounts at 80 to 120. If this is even remotely true, it is outrageous. In the US FDA has approved 6 medical device manufacturers for silicon breast implants.

While 6 silicon breast implant manufacturers approved for 313 million people in the US might seem small, 80 to 120 silicon breast implant manufacturers for 500 million people in the EU is preposterous and beyond oversight. Further, FDA requires that US manufacturers must be able to continually demonstrate the efficacy of their medical devices. No such requirement exists in the EU. 

Medical Device Product Quality Recommendations

• While several approaches to correct the administrative structure should be explored, one approach that might work would be to draw upon CEN and EU Member State Standards Bodies (DIN, AFNOR, BSI, etc.) to identify and/or provide medical device  experts to evaluate medical devices. Their services could be paid for by Notified Bodies, but they must not be employees of for profit Notified Bodies so that their judgments could be compromised.

• Something akin to an FDA 510(k) also should be created with device efficacy built in as major requirement. It isn’t a perfect solution because the 510(k) predicate device requirement doesn’t always avoid device defects in design and materials, but it is overseen by FDA not a private third party.

Medical Device Process Quality

All in all, Notified Bodies do a better job with process quality oversight, not perfect but better than their oversight of medical device product quality. Unfortunately, in their zeal to obtain business, some Notified Bodies could be accused of providing the best oversight money can buy. 

Medical Device Process Quality Recommendations

• Notified Body process quality oversight must be improved, which means that Member State Competent Body oversight of Notified Bodies must improve. Notified Bodies also must have greater awareness of their liability exposure. Thus far they have dodged the proverbial litigation bullet, but this will change in the US as well as in the EU. Presently there are several US lawsuits involving CE marked PIP breast implants in the US and the number of lawsuits will increase.

• FDA’s QSIT (Quality System Inspection Technique) adopted in 1999 as a guidance tool for FDA inspectors and an instructional tool for medical device manufacturers was a clever move that accompanied the adoption of FDA’s Quality System Regulation (QSR) in 1996. It introduced the use of a quality management system as a Good Manufacturing Practices regulatory approach to medical device manufacturing in the US. It also set a serious tone concerning what to expect when FDA conducts a medical device plant inspection. The Internal Quality Management Audit Checklist (ISO 13485:2003/ISO 9001:2000) is the closest approximation I could find to QSIT for the EU. A formal adoption of such a structure for use by EU Notified Bodies and oversight by Member State Competent Bodies could serve the same purpose. Every US medical device manufacturer conducts QSIT audits before being visited by FDA. The same type of rigor should exist for the EU.

• In addition to Member State Competent Bodies acting as Third Party Registrars overseeing their Notified Bodies, some effort should be made to instruct their Notified Bodies to be conversant with and abiding by the legal requirements of ISO/IEC 17021:2006 Conformity Assessment – Requirements for bodies providing audit and certification of management systems. In 2008, I served as legal expert in a national lawsuit in a US Federal Court in Los Angeles. As we proceeded to collect material in legal discovery, I contacted the Registrar for the opposing company to verify that they were the ISO 9001:2000 Registrar for the company. Since the Registrar was a division of a European Third Party that also was a Notified Body with whom I had worked with for some of my EU medical device clients, I anticipated no problem. Instead, I was informed that their attorneys advised them that they could not share such information, which was in clear violation of ISO/IEC 17021:2006. I know that US attorneys are clueless when it comes to such standards, but it quickly became clear that the Registrar also was clueless about the standard. From that point on, the Registrar proceeded to violate the requirements of ISO/IEC 17021:2006 with impunity, including modifying he scope of their ISO 9001:2000 Certification three years after it had been granted, to accommodate their corporate client. We began preparing expanded depositions and inclusion of the Registrar in the lawsuit when the case was settled. Clearly, the Registrar had no moral compass whatsoever. Also, my opinion of the related Notified Body went downhill.

• Notified bodies also must be made aware of their legal obligations in the event of a product liability lawsuit. For example, litigants in US Federal Courts have a legal right to ask for relevant records and documents in discovery such as the Quality Manual and Quality Procedures, Contract Records, Certification Audits, Surveillance Audits, Management Review Minutes, Non Conformity Records, Corrective and Preventive Action Minutes and records, Internal Audit Minutes, design records, process control records, Technical File records, complaints, etc. It makes no difference if these records and documents describe devices manufactured outside of the US. If they are relevant to devices sold in the US, they must be produced or the company can be held in contempt of court and fined. It doesn’t end there. Additional fines and potential criminal prosecution could follow. I mention this because presently I am working as legal expert on a CE Marking lawsuit in US Federal Court where a German manufacturer has been resisting our requests for discovery of their ISO 9001 records and documents and CE Marking Technical Files, etc. under the mistaken impression that a US Federal Court can not compel discovery from a non US manufacturer, not realizing that any manufacturer that sell products in the US is subject to US law.

Conclusion

There is a lot I like about the EU approach to the administration of its new approach Directives. However after seeing first hand the problems with Notified Bodies attempting to find medical device experts and observing mixed success with their administration of quality management system oversight, something must be done to improve the regulatory administrative approach. Also, consideration must be given to the efficacy of their approach as applied in different countries.

When working with a company in Atlanta three years that owned a manufacturing plant in China, I was asked to review their CE Marking materials from China. They had concluded that their Chinese counterparts didn’t understand CE Marking and decided to shift the administration of CE Marking their products to the US. It was about the same time that a US Manufacturer of Heparin was caught up in a controversy where 80 people died and several others were gravely ill from their Heparin sold in the US. The response from the American manufacturer was that they bought their supplies from Consolidation Laboratories in China. At the same time I was looking at pictures in the New York Times of diseased pig intestines draped over concrete sinks in rural China being rinsed with dirty water and shipped to Consolidation Laboratories. The American manufacturer never checked the full depth of their supply chain.

The use of industrial grade silicon instead of medical grade silicon and the resulting problems it has caused thousands of women in the EU and throughout the world is appalling. It is encouraging that the French police have detained the founder of the company. I trust that he might also spend a substantial amount of his remaining time in a French prison.

Clearly it is time to revaluate the effectiveness of the approach for the manufacture of medical devices. I hope that some of my suggestions prove to be useful. As mentioned in my previous blog I would be happy to help. My focus on International Regulatory Compliance has always included both the requirements of regulatory authorities and the legal implications of compliance, non-compliance, documentation and sloppy attention to detail that could result in a lawsuit in a US Federal courtroom. I also focus on product safety and the steps necessary to create a safe product. If you have questions regarding CE Marking lawsuits or medical device regulatory oversight you can contact me for a free preliminary consultation at my e-mail address jameskolka@gmail.com.  

Notified Bodies And CE Marking – Potential Legal Issues In US Lawsuits #3

Continuation

I want to return to the issue of Notified Bodies and the problem with silicon breast implants in the EU. As noted in my two previous blogs, I have observed various problems with Notified Bodies and CE Marking clients over time. Medical devices present a more complex regulatory dimension for CE Marking. In the US, FDA regulates medical devices using its Quality System Regulation (QSR) for medical device design and manufacturing. While FDA employs a quality management system similar to the EU’s ISO 13485, FDA oversight is far more rigorous and intensive with an ability to impose a range of legal sanctions from Warning Letters to Civil and Criminal penalties. Further, FDA can issue a Federal Consent Decree and fines, (e.g. $100 million, $60 million and extended oversight follow up) for the most egregious cases. The key issue is public health and safety.

In the EU, device regulations are not conducted by member state Competent National Authorities, instead they are conducted by one of the 70 approved for-profit Notified Bodies that must be approved by one of the EU’s 27 Competent National Authorities (called competent bodies) to act as a Notified Body for one of the three Medical Devices Directives. Consequently, member states are removed from direct legal enforcement of medical device regulations and hampered in their ability to oversee medical device failures. There is no comparable enforcement structure to FDA.

In the US all medical device manufacturers must have a FDA compliant QSR quality management system. Unless a company wants to manufacture a Class I medical devices not requiring CFR 820.30 design controls it generally must submit a 510(k) to receive FDA approval before manufacturing a medical device or seek Pre Market Approval from FDA and conduct a Clinical Trial to obtain FDA approval before manufacturing a new type of (generally Class III) medical device. FDA has the legal authority to enforce its regulations.

Problems With Notified Body Governmental Oversight

As mentioned in my previous blog, Notified Bodies perform two oversight functions, evaluating and approving medical devices (product safety) and ongoing evaluation of manufacturers’ ISO 13485 Quality Management Systems (process quality). Of the two functions, product quality is the most difficult because of the lack of device experts. To reason that 70 for-profit Notified Bodies can employ 70, 60 or 50 device experts for hundreds of different medical devices in multiple offices around the world isn’t credible. Consequently, the dearth of available device experts will continue to negatively affect the quality of medical devices being manufactured.

As a result, most Notified Bodies focus on the quality management system, ISO 13485 and process quality. The certification audit and surveillance audits operate much like ISO 9001 certification and surveillance audits except that the requirements of the relevant Medical Device Directive are incorporated into the ISO 13485 Quality Management System. Likewise the type of Medical Device(s) will be central to the QMS.

As noted in my previous blog, the quality of Notified Body QMS oversight isn’t always as rigorous as it should be, certainly not as rigorous as an FDA plant inspection. No Notified Body has issued anything comparable to FDA’s QSIT (Quality System Inspection Technique) setting forth the procedure and questions a manufacturer should expect and be able to answer when FDA conducts an on-site inspection of a manufacturing plant. AdvaMed – Advanced Technology Association has developed papers, Different Points to Consider When Preparing For An FDA Inspection for different QSIT Subsystems. There is no comparable preparation for an audit by a Notified Body.

This is not to say that audits by Notified Bodies are treated lightly by medical device manufacturers rather it speaks to the legal authority of an FDA audit when compared to the legal authority of Notified Body audits. In addition to the audit example described in my previous blog where a Notified Body wrote good observations for a Class III medical device manufacturer but failed to issue non-conformities, did not serve their client well. Whether this was done to placate a client to retain their business isn’t clear. What it did accomplish was to prompt their client to ask me if I thought they would survive an FDA site inspection, to which I said no. 

In contrast, FDA at the very least would have issued a Warning Letter and might even have shut down the facility until major changes were implemented. This is not the only case where I have observed a Notified Body conduct an “audit-lite.” A few other examples are listed below:

• A colleague and I spent two days at a medical device manufacturer’s only US CE Marking plant in Arizona while conducting a GAP Analysis for the manufacturer. They wanted to extend CE Marking capability to all of their US manufacturing plants and asked if we could evaluate their Arizona operation. When we arrived at the plant we asked to examine their Technical Files for medical devices being manufactured at the Arizona plant. To which the plant manager responded, “What’s a Technical File?” Following this exchange we proceeded to conduct our audit. We found storage of medical devices in a warehouse lacking heating and cooling was having a serious adverse effect on device quality. We also found boxes containing devices that were marked with the corporate address 1000 miles away, but not the address of the plant in Arizona that was CE Marking the devices. Several more problems were found. We recommended that they identify the unique features of each QMS, but integrate their QSR and ISO 13485 Quality Management Systems for greater control in the future.

• I recently received a call from a Medical Device Manufacturer in Atlanta asking if I could meet them at their corporate office for consultation. They had just been told by their Notified Body that they received two major non-conformances on their most recent surveillance audit and had one month to make the necessary correction or they could no longer CE Mark their medical devices. The quality and regulatory managers flew in from the manufacturing plant in question with the surveillance audit report. The managers were shocked because this was their fifth surveillance audit report and previously they had not received any non-conformances. Nothing had changed in their manufacturing operation. The Notified Body informed them that their Competent National Authority (competent body) had just completed a review of all of their audits and found problems with their findings. The Notified Body was informed that they had to meet with all of their clients and inform of these changes and the reason for the changes or the Notified Body would be stripped of its CE Marking authority. Fortunately, my client was able to make the necessary corrections and continue CE Marking their medical devices.

• In another case I visited another manufacturing client in California at the request of their medical device insurance company to examine their Quality Management System and complaint handling system. The manufacturer had experienced some difficulties and wanted a legal perspective on corrective steps that might be taken. The quality manager mentioned that they had a recent surveillance audit from their Notified Body. (The manufacturer made radioactive plates for Magnetic Resonance Imaging machines.) They were surprised that the Notified Body device expert seemed to be afraid of entering the manufacturing area for fear of exposure to radiation. They weren’t convinced that he was much of an expert. The company has dealt with many experts in radioactive devices throughout their operation.

These are not idiosyncratic observations. While I have worked with several exceptional Notified Bodies administering CE Marking regulatory oversight for the EU Medical Devices Directives, they too have experienced glitches and these have been corrected when discovered. Clearly, strong Competent Body oversight is vital to the process. 

As mentioned previously there also are Notified Bodies more motivated by making money than quality medical device regulatory oversight. A colleague of mine encountered one such Notified Body a few years ago when working with a company that manufactured active implantable medical devices. He helped the manufacturer meet with the FDA regional office and review their quality management system. He was then asked by the manufacturer if he would review their most recent Notified Body surveillance audit, which he did. They asked his opinion and he said it was inadequate, which angered the Notified Body.

He subsequently learned that the company, however, was not fully candid with him, the FDA and the Notified Body. Not only were there manufacturing problems, four people had died from their implants and several others were experiencing serious problems with the device. FDA took action and several product liability lawsuits followed.

Had plaintiffs’ attorneys realized the role of the Notified Body in CE Marking these devices they could have sought Technical Files, ISO 13485 records, documents and notified body Certification Audits and Surveillance Audits in discovery to see what additional useful information could be obtained for use in the lawsuits. Notified Bodies are not exempt from US lawsuits. Further, the Notified Bodies could have been sued directly if their regulatory behavior could be partially attributed to device failures. The irony here is that the notified Body never realized how close they came to becoming a part of the lawsuits.

Observation – Privatized Oversight

The concept of privatized regulatory oversight is not unique. However, fragmented regulatory oversight involving 27 different Competent National Authorities (Competent Bodies) of different size, expertise and financial capability overseeing 70 Notified Bodies operating on their behalf is unique and extremely cumbersome. Until the structure is corrected, problems will continue to arise. The Friday January 27, 2012 issue of the New York Times contains an article about the breast implant manufacturer Poly Implants Prothèses, the founder Jean-Claude Mas and the apparently undetected use of industrial grade silicon in place of medical grade silicon.

The problem now is the immediate solution and the long-term solution. I understand the desire to create a strong EU structure while preserving national sovereignty. My political science and legal training tells me that it is possible, not easy but possible. I would be happy to help. 

My next blog will conclude this series and specifically address the problem with the silicon breast implants and prospective solutions. My focus on International Regulatory Compliance has always included both the requirements of regulatory authorities and the legal implications of compliance, non-compliance, documentation and sloppy attention to detail that could result in a lawsuit in a US Federal courtroom. I also focus on product safety and the steps necessary to create a safe product. If you have questions regarding CE Marking lawsuits you can contact me for a free preliminary consultation at my e-mail address jameskolka@gmail.com. 

Notified Bodies And CE Marking – Potential Legal Issues In US CE Marking Lawsuits #1

Introduction

I received an e-mail this week asking this question, “Are you aware whether or not the notified bodies in Europe are expected to possess professional indemnity insurance, to cover them in cases of a poor opinion of compliance or failure of post Market surveillance, with thanks for your advice.”

I answered, “Yes, in every new approach Directive there is an Annex that spells out the criteria for notified bodies. For Example, in the 2006/42/EC Machinery Directive, Annex XI sets forth, "Minimum criteria to be taken into account by Member States for the notification of bodies" Paragraph 6 states, "The body shall take out liability insurance unless its liability is assumed by the State in accordance with national law or the Member State itself is directly responsible for the tests."

Notified Body Requirements

The question about notified body “indemnity insurance” raises a number of questions that should be explored concerning the EU legal requirements for notified bodies and their potential legal implications in US courts. The full list is stated below:

Minimum criteria to be taken into account by Member States for the notification bodies 

1. The body, its director and staff responsible for carrying out the verification tests shall not be the designer, manufacturer, supplier, or installer of machines which they inspect, nor the authorized representative of any of these parties. They shall not become involved, either directly or as authorized representatives, in the design, construction, marketing or maintenance of the machines. This does not preclude the possibility of exchanges of technical information between the manufacturer and the body.

2. The body and its staff shall carry out the verification tests with the highest degree of professional integrity and technical competence and shall be free from all pressures and inducements, particularly financial, which might influence their judgments on the results of their inspection, especially from persons or groups with an interest in the result in result of verifications.

3. For each category of machinery for which it is notified, the body must possess personnel with technical knowledge and sufficient and appropriate experience to perform a conformity assessment. It must have the means necessary to complete the technical and administrative tasks connected with the implementation of the checks in an appropriate manner, it must also have access to the equipment necessary for the exceptional checks.

4. The staff responsible for inspection shall have:

-- sound technical knowledge and vocational training,

-- satisfactory knowledge of the requirements of the tests they carry out and adequate experience of such tests,

-- the ability to draw up the certificates, records and reports required to authenticate the performance of the tests.

5. The impartiality of inspection staff shall be guaranteed. The remuneration shall not depend on the number of tests carry out or on the results of such tests.

6. The Body shall take liability insurance unless its liability is assumed by the State in accordance with national law, or the Member State itself is directly responsible for the tests.

7. The staff of the body shall be bound to observe professional secrecy with regard to all information obtained in carrying out its tasks (except vis-à-vis the competent administrative authorities of the State  in which its activities are carried out) under this Directive or any provision of national law giving effect to it.

8. Notified bodies shall participate in coordination activities. They shall also take part directly or be represented in European standardization, or ensure that they know the situation in respect of relevant standards.

9. Member states may take all necessary measures they regard as necessary in order to ensure that, in the event of cessation of the activities of a notified body, the files of its customers are sent to another body or are made available to the Member State which has notified it.

Notified Bodies 

Notified bodies are created by each New Approach Directive.  The criteria are established by each Directive.  Notification may be to a specific clause, such as Annex IV of the Machinery Directive dealing with dangerous machines, which is the only clause to which a body may be notified for that Directive. Notification also may be confined to those clauses for which it has technical competence or it may extend to all of the clauses of a directive.  The decision belongs to Competent National Authorities who use the EN 45000 series to evaluate notified bodies. When a Competent National Authority approves one of their third parties for a Directive, they “notify” the European Commission. The Commission periodically publishes the list of notified bodies in The Official Journal of the European Communities.

Product Safety and Process Quality--Two Elements of CE Marking A Product 

In his preface to The Guide to the Implementation of Community Harmonization Directives Based on the New Approach and the Global Approach, Brussels, 1995, Vice President of the European Commission, Martin Bangeman stated the following:

The novelty of this new approach resides essentially in the use of community technical rules of “quality instruments” such as European Standardization and conformity assessment procedures (testing, product certification, certification of manufacturers’ quality control procedures, accreditation, etc.).  These instruments, drawn up on the basis of consensus of all the economic partners involved, enable manufacturers to affix the CE marking--a real “technical passport”--to their industrial products, which must conform to these community directives.

Considered one of the architects of the new approach, vice president Bangeman’s quote deserves some attention.  To begin, when he talks about a “consensus of all the economic partners involved” he is referring to the fact that the CEN, CENELEC and ETSI working groups that draft EN safety standards are comprised of manufacturer representatives, representatives of Member State standards organizations (e.g., BSI, DIN, AFNOR, etc.), testing laboratories, academic faculty and in some cases consumer representatives.  While Member State standards organizations direct working group schedules, there is a conviction that the affected parties are participating in writing the standards.

The reference to “quality instruments” such as European standardization and conformity assessment procedures points to two aspects of virtually all new approach directives.  One aspect is the element of product safety. The technical file referred to in most directives contains a checklist of the directive’s essential safety requirements and the EN harmonized safety standards and/or the tests performed and approvals granted which a manufacturer has used to demonstrate conformity to the Directive’s essential safety requirements.  Generally, among those tests will be an application of the principles of safety integration applied to the product in question and a risk assessment. The technical file should demonstrate and record the companies’ efforts to achieve an acceptable level of product safety.

The second aspect is the element of process quality. Once an acceptable level of product safety has been built into a product, the manufacturing process must be able to assure consistent quality so that products number 5, 905, and 20,005 are of consistent and dependable quality. This dual objective of achieving acceptable product safety and consistent process quality will be familiar to manufacturers of regulated products such as medical devices using ISO 13485, and ISO 9001 for manufacturers of products covered by other Directives.

Conclusion

Notified bodies play an integral role in New Approach Directives such as the Medical Devices Directives and variable role in other New Approach Directives, e.g. except for Annex IV of the Machinery Directive where notified body involvement is required, manufacturers self-certify to the requirements of the Directive.

The areas where third parties are “notified” varies for each Directive. Since Notified Bodies (along with ISO 9001 Registrars) will increasingly become involved in CE Marking lawsuits in US Federal Courts, I want to examine notified body involvement and behavior since the beginning of CE Marking products and identify areas where notified body involvement in US lawsuits should be anticipated.

My focus on International Regulatory Compliance has always included both the requirements of regulatory authorities and the legal implications of compliance, non-compliance, documentation and sloppy attention to detail that could result in a lawsuit in a US Federal courtroom. I also focus on product safety and the steps necessary to create a safe product. If you have questions regarding CE Marking lawsuits you can contact me for a free preliminary consultation at my e-mail address jameskolka@gmail.com.  

CE Marking Lawsuits – Applying Forensic Law To Evidence & Discovery

Introduction

As I mentioned in my previous Blog, US Federal Courts – The New Venue For CE Marking Lawsuits, posted on November 30, 2011, we can expect to see an increasing number of CE Marking lawsuits in US Federal Courts. The rationale for the increased number of lawsuits is spelled out in the Blog. I have previously mentioned that I am serving as legal expert in three such lawsuits in US Federal Courts. The earliest lawsuit is nearing completion and appears to have met with success in translating European EN Safety Standards and EU Directive Essential Safety Requirements in a US courtroom. The other two lawsuits are still underway. I also mentioned having served as legal expert in lawsuits involving ISO 9001. These have been settled out of court, however, based on some recent inquiries I anticipate more such lawsuits in the future.

The purpose of today’s Blog is to revisit a few of the previous observations and amplify the points being made. I noted previously that US litigation attorneys often proceed in a somewhat routine fashion not fully understanding the different product safety requirements of EU New Approach Safety Directives and EN safety standards. Also as noted, I have seen botched discovery requests and frustrated Judges regarding ISO 9001 records and document requests in discovery. 

New Territory

This area, CE Marking New Approach Safety Directives, often intermingled with a quality management system, such as ISO 9001 is new territory that requires competent legal understanding if litigation attorneys and defense counsel hope to succeed on behalf of their respective clients.

To begin there are 27 New Approach Safety Directives, drafted at different times. Several are in various states of revision and new Directive combinations. These Directives affect approximately 65% of products entering the EU. They range from Directives addressing Machinery Safety, Medical Devices (General, Active Implantable, In Vitro Diagnostic), Toy Safety, Low Voltage, Electromagnetic Compatibility, Pressure Equipment, Equipment and Protective Systems in Potentially Explosive Atmospheres (ATEX), Construction Products, Personal Protective Equipment, Radio and Telecommunications Terminal Equipment to mention some of the more prominent Directives. 

Each Directive also has Essential Safety Requirements and EN standards that allow for demonstration of conformity to the Directive’s essential safety requirements. There are thousands of standards that are reviewed every 5 to 7 years to consider whether they should be maintained in their present state, revised or eliminated. As noted in the prior Blog, the revision of these standards is now coordinated between the EU Standards Bodies, CEN, CENELEC and ETSI and ISO and IEC to improve the revision process and invite EU standards expertise into these considerations. Also participating in ISO and IEC deliberations on behalf of United States is the American National Standards Institute (ANSI). Consequently, these revised standards will become both American and EU standards. Therefore, the time when a product is manufactured could determine if a standard in question was also an American Standard, if that issue is relevant to a lawsuit.

Also, depending on the Directive or Directives in question and the nature and safety of a product, a company might have chosen what the Europeans call a Conformity Assessment Procedure to assure that the product is manufactured at a consistent quality level. In these cases, third parties which the Europeans call “Notified Bodies” will be involved in the product compliance process. Therefore, notified body records, often including ISO 9001 Quality Management System documents and records could be involved.

It is critical for litigation attorneys and defense counsel to understand how these safety standards are applied and how this information could critically impact a lawsuit affecting their clients. Sophomoric American assumptions could adversely affect the outcome of a lawsuit. 

Timing

As noted in my previous Blog, timing is critical to understanding the relevant facts concerning a lawsuit. It is important to know when a product is manufactured in order to determine the legal status of a Directive, e.g. whether or not it had been revised at the time of design and manufacture, and it is important to know which standards apply to a product. If a Conformity Assessment Procedure was involved and a Notified Body also was involved, certification audits and surveillance audits could become important to the disposition of a lawsuit. Likewise, it is important to know how many Directives might be involved in the manufacture of a product.

For example, I have worked with machinery manufacturers whose machines had to comply with the Machinery Directive, Low Voltage Directive, Electromagnetic Compatibility Directive, Pressure Equipment Directive and the Explosive Atmospheres Directive. Therefore the requirements of each directive and the standards necessary to comply with the requirements of each directive need to be examined. Likewise, it is critical to know what requirements were in place when the product was manufactured. Of course, attorneys will want to know how this all might be litigated in a US Federal Court. 

Observation

In previous Blogs where the topic was a malfunctioning product such as machine, specific compliance with the requirements of these New Approach Safety Directives can be examined to see if the company actually attempted to satisfy the requirements of the Directives and the relevant standards. In one case presently being litigated in a US Federal Court, it was clear that the company, a US machinery manufacturer, did not create a Technical File containing all of the steps required by the manufacturer to comply with the Directive. The file also contained no risk assessment standard and risk assessment judgments.  Further, after two accidents that killed one worker in the EU and maimed another worker in the US who will require 24 medical care for the rest of his life, it was clear that the company did not comply with the safety requirements of the directive and this failure caused both accidents. 

Forensic Law   

In order to address these cases and effectively use this information in a US Federal Court, it is necessary how these Directives and their Standards interplay and the status of each at the time the machine in question was designed and manufactured. Simple assumptions will not work. Knowing when critical components were manufactured also is important as well as the date that the product itself is manufactured. Knowing how the EU directives and standards work is different, but it can be successfully tackled and lawsuits can be won.

I first encountered the term “forensic” when I received a call several years ago from young man was working with a law firm applying the requirements of ISO 9001 and ISO 9004 to some product failure cases in Atlanta. I asked what his background was and he said he was a forensic engineer. 

Since then, and in a totally different application in California involving a product that was causing a medical device manufacturer to experience manufacturing difficulties with diabetic test trips, I was asked to determine if a supplier had failed to follow requirements of its ISO 9001 Quality Management System and if that failure caused the test strip difficulties. It did. I also was working with a forensic accounting firm who were determining if the financial loss calculated by the manufacturer was accurate. It was. 

The term forensic applies equally to the law and litigation. Attorneys continually attempt to dissect products and events to understand what happened and apply this knowledge on behalf of their clients. In the case of the 27 EU New Approach Safety Directives and thousands of EN harmonized safety standards the forensic analysis is complex, but doable. The biggest problem I have observed are US attorneys who transmogrify an EU legal issue into a more familiar American setting thereby mutilating the critical issues and facts affecting their clients.  

Conclusion

To successfully tackle a CE Marking lawsuit, it is necessary to apply forensic analysis to the Directives and Standards that apply to a case. As noted in my prior Blog, while it can be hard breaking litigation and defense attorneys of some bad habits and reining in their egos, it is to their advantage to approach a lawsuit having all of their facts in order and achieving the best possible result for their client. Fortunately, I’ve worked with several attorneys who have achieved this objective and prevailed on behalf of their clients.

My focus on International Regulatory Compliance has always included both the requirements of regulatory authorities and the legal implications of compliance, non-compliance, documentation and sloppy attention to detail that could result in a lawsuit in a Federal or State courtroom. I also focus on product safety and the steps necessary to create a safe product. If you have questions concerning EU Directives and Standards and product liability litigation, you can contact me for a free preliminary consultation at my new e-mail address jameskolka@gmail.com.

US Federal Courts – The New Venue For CE Marking Lawsuits

 

Introduction

I have discussed the CE Marking implications of product liability lawsuits in US Federal Courts several times. I want to expand on this topic. As mentioned in previous blogs, presently, I am serving as legal expert in three lawsuits involving the EU Machinery Directive in US Federal Courts. ISO 9001 also is involved in two of these cases. 

As long as one of the litigants is a US resident (individual or corporation), the dollar amount meets federal monetary requirements and a legitimate cause of action exists, the suit can proceed. This means the following types of lawsuits can be filed:

• Non US citizens, corporations or companies that suffer injury and/or damage from a CE Marked product manufactured by a US corporation or company can file a lawsuit, e.g. product liability claim, breach of warranty, breach of contract, etc. in a US Federal Court.

• US citizens, corporations or companies that suffer injury and/or damage from a CE Marked product manufactured by a US, EU or other foreign corporation or company can file a lawsuit, e.g. product liability claim, breach of warranty, breach of contract, etc. in a US Federal Court.

What Does This Mean?

To begin, it means that citizens of other countries who are injured by a CE Marked product manufactured by a US company can bring a product liability lawsuit against a company, a legal remedy not available in their own country. It also means that a foreign manufacturer of a CE Marked product that injures a US resident or company can be sued for damages in a US product liability lawsuit. It is a reason that manufacturers can anticipate product liability lawsuits for their CE Marked product failures in US Federal Courts. It is one of the reasons that I am presently serving as legal expert in three CE Marking lawsuits in three different Federal Courts. I have also served as a legal expert in ISO 9001 lawsuits between US corporations and EU corporations. 

For foreign companies selling their CE Marked products in the US it likely will be their first exposure to legal discovery. From what I have experienced thus far, it means that many of these companies will experience requests for information and documentation for the first time and try to resist turning over anything that might be injurious to their legal position. That certainly has been the behavior of some German corporations involved in a few product liability lawsuits. Thus far, it has not been the behavior of ISO 9001 lawsuits between UK corporations and US corporations. The sample, however, is quite small.

Another surprise is the request for CE Marking Technical Files. As mentioned in previous blogs, one of the cases I am working on involves a US corporation manufacturing a CE Marked machine. They turned over a Technical File that has to be described as a junk file or gibberish. Clearly, the company had not paid attention to or chose to ignore the specific requirements of the Machinery Directive. The manufacturer also was found to be duplicitous in their dealings with UK authorities and opposing counsel. Fortunately, as this case moves along, the failure to comply with the requirements of the Directive have become apparent to the Court and likely will result in an adverse judgment which most likely will be settled out of court to the monetary detriment of the US machinery manufacturer. 

Of course, the request for information contained in Technical Files will be an even bigger surprise for EU manufacturers of CE Marked products and the intense scrutiny concerning the quality of compliance of these manufacturers with EU Directives. One attorney asked me why EU EN harmonized standards would be relevant in a US court. After all they are not  American standards.

I told him that EN standards like all ISO and IEC standards are revised on a periodic basis, approximately every 5 to 7 years. By agreement between the European Committee for Standardization (CEN) and ISO and the European Committee for Electotechnical Standardization (CENELEC) with IEC the new standards that emerge from this collaboration will be both International and European standards. In addition and even more important in the US, ANSI (American National Standards Institute) participates in all of the ISO and IEC standards deliberations and revisions. Consequently, at the end of the revision process the new standards also will be both European and American standards.

Litigation Attorneys

The role of litigation attorneys dealing with CE Marking Directives, CE Marked products, European standards and occasionally ISO 9001 or ISO 13485 is another issue. Often I have found that the attorneys proceed in a somewhat routine fashion not fully understanding the product requirements and the issues they are dealing with. On occasion, I have seen botched discovery requests and frustrated Judges regarding ISO 9001 records and documents requests.

Also, I have seen some, not all, attorneys become rather arrogant and possessive about "their" lawsuit and not helpful in providing information so that I can be of greater value to their case. They tend to think they can puzzle their way through the CE Marking process. However, with 27 New Approach Directives in various stages of revision and new combinations and thousands of EN harmonized standards in various stages of revision, it isn’t remotely as simple as it might appar. When I do work with attorneys who are open and share the issues at hand, the collaboration can work extremely well. My role is to serve as a legal expert not a litigation attorney.

Timing

Timing is critical to understanding the relevant facts concerning a lawsuit. For example, in some of the Machinery Directive lawsuits it is important to know when the machine was manufactured, the status of the Directive, e.g. revisions of the relevant EN standards that should have been followed to satisfy the Annex I Essential Health and Safety and Requirements.  It is also important to know what other Directives may be involved. I have worked on CE Marking several machines that involved the Machinery Directive, Low Voltage Directive, EMC Directive, Pressure Equipment Directive and Explosive Atmospheres (ATEX) Directive. Other Directives could be added today, e.g. RoHS2. This information may seem arcane, but it could be quite critical to the manufacturer’s actions regarding the machine. The same is true for ISO 9001, e.g. are we talking about ISO 9001:1994, ISO 9001: 2000 or ISO 9001: 2008? I’ve seen several instances where the attorneys did not understand the revision of the standards and didn’t realize that there was continuity in compliance with one standard to the next.

The same issue comes into play regarding EN standards. For example, I recently discovered that CE Marked components that were incorporated in a machine by a client were in fact “out of date.” We called the component manufacturer and brought this matter to their attention saying that we have to have components that comply with current EN standards. After some grumbling, the component suppliers produced components compliant with the most recent standards. This may seem like a small matter, but it could be quite costly for the manufacturer in case of a product liability lawsuit.

Conclusion

While it can be hard breaking litigation attorneys of some bad habits and reining in their egos, it is to their advantage to approach a lawsuit having all of their facts in order to achieve the best possible result for their client. Fortunately, I’ve worked with several attorneys who have achieved this objective and prevailed on behalf of their clients. My focus on International Regulatory Compliance has always included both the requirements of regulatory authorities and the legal implications of compliance, non-compliance, documentation and sloppy attention to detail that could result in a lawsuit in a Federal or State courtroom. I also focus on product safety and the steps necessary to create a safe product. If you have questions concerning medical device litigation, you can contact me for a free preliminary consultation at my new e-mail address jameskolka@gmail.com.

Market Surveillance #3 – To Be Or Not To Be – When, Is The Question

 

Continuation

I decided to add a third installment to my blog on Market Surveillance and the revised Machinery Directive 2006/42/EC. As noted several times the impetus for these comments has been driven by serving as legal expert in a lawsuit involving a CE Marked machine that has killed one worker and injured another worker who will need 24 hour care for the rest of his life. These accidents involved the same machine model in two separate incidents in two different countries.

While the Technical File was a junk file that did not comply with the requirements of the Machinery Directive, the contents of the file and the pathetic state of compliance was unknown until the first accident occurred and the file was turned over to the Health and Safety Executive (HSE) in the UK. In reality, the pathetic state of compliance is still unknown because, as noted in the previous blog, HSE investigates workplace accidents and BIS (Department for Business Innovation and Skills) the Competent UK Authority that oversees CE Marking for the Machinery Directive has not received the HSE investigation report. Meanwhile, the non-compliant machines are still on the market.

CE Marking Litigation And Its Future

I only reiterate these facts because in the past two weeks, I have received calls from two new clients involved in lawsuits in the US concerning CE Marking for the Machinery Directive. I anticipate more in the future. There are several reasons for this increased litigation activity, among them:

• CE Marking safety requirements and standards for machines have grown in number and sophistication since the Machinery Directive was first published on 14 June 1989.

• Following the Vienna and Dresden agreements between the EU Standards Bodies (CEN and CENELEC) with ISO and IEC respectively (to avoid duplicating standards writing efforts) these new international standards writing activities automatically include the participation of ANSI (American National Standards Institute) in drafting ISO & IEC standards resulting in EN ISO and EN IEC standards that are also American National Standards, recognized by US Courts of Law. In sum, EN standards are rapidly becoming American standards.

• US Federal Courts offer a litigation venue for product liability, Breach of Warranty and Breach of Contract lawsuits concerning CE Marking between US Citizens and US machinery manufacturers, US Citizens and EU machinery manufacturers and EU Citizens and US machinery manufacturers.

• The oft cited 2002 Minnesota case where a California Packaging Machinery Manufacturer sold a less safe machine in the US injuring a worker who will require 24 hour care for the rest of his life (it didn’t have a laser light curtain to turn off the machine when a worker entered the area of machinery activity), but sold safer CE Marked machines with laser light curtains in the EU for 6 years because of the Machinery Directive safety requirements, resulted in a $35 million punitive damages award (the manufacturer knew how to make a safer machine and chose not to do so). This means that US manufacturers who follow the same path of selling less safe machines in the US and safer machines in the EU and EU manufacturers who sell non CE Marked less safe machines in the US can expect a similar result in US Courts. It is a whole new area of litigation for American trial attorneys.

• Just as trial attorneys can ask for ISO 9001 records and documents that are relevant to a product liability lawsuit in the US and EU, they can now ask for Machinery Directive Technical File records and documents in discovery in Product Liability, Breach of Warranty and Breach of Contract lawsuits. The fact that these records and documents may belong to a European manufacturer is irrelevant. Whether the EU manufacturer is suing or being sued the cause of action arises from doing business in the US, making the litigants subject to US Courts and US rules of civil procedure.

These are a few of the legal nuances for US Courts of Law brought about by the evolution of the Machinery Directive and its supporting standards writing activities.

The Response of EU Competent Authorities 

In future blogs I will spend more time examining the substance of Decision No 768/2008/EC of the European Parliament and the Council of 9 July 2008 On a Common Framework For the Marketing Of Products and Repealing Council Decision 93/465/EEC. In the preceding two blogs (July 30 & August 15) and this blog, however, I have concentrated on administrative issues not touched on in Decision No 768/2008/EC that I believe are critical to the success of effective Market Surveillance as it relates to the Machinery Directive.

In the section titled “A View Thoughts” in the preceding August 15 blog, my Fifth recommendation was, “once a complaint or accident involving a CE Marked machine is recorded by a Competent Authority, a checklist protocol should be developed utilizing Annex VII of Machinery Directive 2006/42/EC to determine if all the elements of a Technical File contained in A. Points 1,2 & 3 are compliant. Listed below are those points

1. The technical files shall comprise the following:

  (a) a  construction file including:

-- a general description of the machinery,

-- the overall drawing of the machinery and drawings of the control circuits, as well as the pertinent descriptions and explanations necessary for understanding the operation of the machinery,

-- full detailed drawings, accompanied by any calculation notes, test results, certificates, etc., required to check the conformity of the machinery with the essential health and safety requirements,

-- the documentation on risk assessment demonstrating the procedure followed, including:

  (i) a list of the essential health and safety requirements which apply to the machinery,

  (ii) the description of the protective measures implemented to eliminate identified hazards or to reduce risks, when appropriate, the indication of the residual risks associated with machinery,

-- the standards and other technical specifications used, including the essential health and safety requirements covered by these standards,

-- any technical report giving the results of the tests carried out either by the manufacturer or by a body chosen by the manufacturer or his authorized representative,

-- a copy of the instructions for the machinery,

-- where appropriate, the declaration of incorporation for included partly completed machinery and the relevant assembly instructions for such machinery,

-- a copy of the EC declaration of conformity.

 (b) for series manufacture, the internal measures that will be implemented to ensure that the machinery remains in conformity with the provisions of the Directive.

The manufacturer must carry out necessary research and tests on components, fittings or the completed machinery to determine whether by its design or construction it is capable of being assembled and put into service safely. The relevant reports and results shall be included in the technical file.

2. The Technical file referred to in point 1 must be made available to the competent authorities of the Member States for at least 10 years following the date of manufacture of machinery or, in the case of series manufacture, for the last unit produced. (Emphasis added)

The technical file does not have to be located in the territory of the Community, nor does it have to be permanently available in material form. However, it must be capable of being assembled and made available within a period of time commensurate with its complexity by the person designated in the EC declaration of conformity. (I suggested 48 hours, similar to the Medical Devices Directives)

The Technical file does not have to include detailed plans or any other specific information as regards the subassemblies used for the manufacture of the machinery unless a knowledge of them is a central for verification of conformity with the essential health and safety requirements.

3. Failure to present the technical file in response to a duly reasoned request by the competent national authorities may constitute sufficient grounds for doubting the conformity of the machinery in question with the essential health and safety requirements. (Emphasis added)

Conclusion

As noted in the two previous blogs, I think these types of steps are essential for effective Market Surveillance for the revised Machinery Directive 2004/42/EC. I also noted previously that I would like to work with European manufacturers and companies on steps to reduce their liability exposure in the US market. It seems to fit the European philosophical approach to product safety and would help EU firms concerned about the litigious nature about the US marketplace. If anyone is interested in exploring these topics further, please contact me at jameskolka@gmail.com or jim@jameskolka.com. 

Market Surveillance #2 – To Be Or Not To Be – When, Is The Question

The Quandary

The preceding blog described some of the issues and concerns I have encountered working with companies CE Marking their products for the EU. Recently, however, my concern has been heightened by issues raised in an ongoing lawsuit in the US & EU regarding a machinery manufacturer whose machines have caused the death of one worker and a severe injury to another worker who will require 24 hour care for the rest of his life. 

While Decision No 768/2008/EC of the European Parliament and the Council of 9 July 2008 On a Common Framework For the Marketing Of Products and Repealing Council Decision 93/465/EEC presumably went into effect on 1 January 2010, the implementation details are evolving rather slowly.

The lawsuit underscores some of problems. In the UK, an industrial workplace accident is investigated by HSE (Health and Safety Executive). The fact that a machine is CE marked is of no immediate concern to HSE, their focus, as it should be, is on the accident. When they conclude their investigation, they will pass on their findings to BIS (Department for Business Innovation & Skills) the CE Marking Conformity Assessment Body in the UK. It is a nice linear progression, but it delays immediate action concerning the CE Mark of the machinery manufacturer and disadvantages the family of the worker who was killed in the accident and leaves similar machines in place throughout the EU to potentially cause more workplace injuries.

As noted in previous blogs, in my opinion the machine in question did not begin to satisfy CE Marking requirements of the Machinery Directive 93/37/EC at the time the machine in question was manufactured:

A Comparison – The Manufacturer vs. Annex V, paragraph 3

The requirements for the technical file can be found in Annex V, paragraph 3 of the Machinery Directive where it is identified as a, “technical construction file”:

“(a.) a technical construction file comprising:

-- an overall drawing of the machinery together with drawings of the control circuits,

-- full detailed drawings, accompanied by any calculation notes, test results, etc., required to check the conformity of the machinery with the essential health and safety requirements

-- a list of:

   -- the essential requirements of this Directive (a sample checklist and sample

      identification of relevant EN harmonized technical standards is attached) 

   -- standards, and

-- a description of methods adopted to eliminate hazards presented by the machinery,

-- if he so desires, any technical report or certificate obtained from a competent body or laboratory,

-- if he declares conformity with a harmonized standard which provides therefore, any technical report giving the results of tests carried out in his choice either by himself or by a competent body or laboratory

-- a copy of the instructions for the machinery;

(b.) for series manufacture, the internal measures that will be implemented to ensure that the machinery remains in conformity with the provisions of the Directive.

The manufacturer must carry out necessary research or tests on components, fittings or the completed machine to determine whether by its design or construction, the machine is capable of being erected and put into service safely.

Failure to present the documentation in response to a duly substantiated request by the competent national authorities may constitute sufficient grounds for doubting the presumption of conformity with the requirements of the directive."

While the language is quaint, it sets forth the substance of a technical file. The reference above in (b.) to series manufacture refers to the quality system.

As noted in previous blogs, in my opinion the machine in question did not begin to satisfy CE Marking requirements of the Machinery Directive:

• There was no coherent Technical File

• No Part A providing an index containing all of the elements in the file

• No Annex I Essential Health and Safety Requirements Checklist identifying which essential health and safety requirements the manufacturer applied to their Product Family Machines

• No complete listing of EN harmonized standards selected to demonstrate conformity to the relevant Essential and Safety Requirements of the Directive

• No listing of EMC standards

• No ISO 14121-1:1999 Risk Assessment, FMEA, FTA

• No identification of the manufacturer’s certification to ISO 9001: 2000

• No complete EC Declaration of Conformity

• No identification of an Authorized Representative on the Declaration of Conformity

From my perspective, the machinery manufacturer clearly failed to satisfy the safety requirements of the Machinery Directive. There is Prima Facie evidence that the machine is not compliant with the Machinery Directive. I believe that the manufacturer should have had his machines impounded until he could present documentation demonstrating compliance.

Annex V, paragraph 3 (b), final paragraph:

Failure to present the documentation in response to a duly substantiated request by the competent national authorities may constitute sufficient grounds for doubting the presumption of conformity with the requirements of the directive."

There is no reason that parallel investigations cannot proceed, each triggered by a machine that caused a fatal accident. I just received an e-mail from an engineer, “I am working on a project in Ireland and curious to know what penalty a manufacturer would face if they knowingly provided an EC Declaration of Conformity under the Machinery Directive for a machine that did not comply with the Essential Safety Requirements.” I suggested that he contact the Competent Authority in Ireland and the country where the machine was manufactured. I wish I had confidence that he would be listened to carefully and could expect action if he is correct in his assertion

Presently, I don’t know what will happen. While it may not be intended, the HSE handoff to BIS suggests a certain bureaucratic logical cleanliness in response. I don’t blame HSE because they are doing what OSHA (Occupational Safety and Health Administration) would do in the United States in the case of an accident. In the US, however, there is no BIS Competent Authority overseeing machinery safety. Perhaps a complaint could be lodged with the US Consumer Products Safety Commission and action might be taken. Unfortunately, the aversion of some Americans to any kind of regulation coupled with corporate distaste for all regulation make it difficult to create a regulatory response in the US akin to FDA oversight for drugs and medical devices.

The most effective response in the US comes through the court system via product liability, breach of warranty, breach of contract and other lawsuits challenging manufacturers in a court of law. At present, there is no equivalent legal response in the EU, so the oversight of Competent Authorities in the EU Member States is critical to the successful implementation of the Machinery Directive and related Directives. The issue then is how to go about this task to improve compliance.

A Few Thoughts

In my first “Market Surveillance” blog posted on 30 July 2011, I mentioned several issues and possible responses concerning self-certified machines:

• First, I believe it is critical that Part A of a Technical File should be a requirement of all machinery manufacturers (past and present) and it should be filed with a reliable entity, in my opinion a Competent Body, and it should be entered electronically in a shared European Commission Competent Body Database.

• Second, I also believe that an Annex I Essential Health and Safety Requirements Checklist identifying which essential requirements apply to the machine in question and which EN harmonized standards will be used to demonstrate conformity, linked to Part A of the Technical File should be filed with the same Competent Body entered into the same shared European Commission Competent Body Database.

• Third, as noted in my prior blog, I don’t think either Authorized Representatives or Notified Bodies should assume this task. In my personal experience, I have found both to be widely variable in behavior and capability and too anxious to make money in most everything they do.

• Fourth, a protocol should be developed to trigger a response to complaints about CE Marked products and potential investigation of reports of accidents involving CE Marked products, independent of workplace accident investigations conducted by agencies such as HSE. The two responses should be separate from one another. While accidents must be investigated, non-compliant CE Marked machines should be impounded or removed so that additional accidents don’t occur.

• Fifth, once a complaint or accident involving a CE Marked machine is recorded by a Competent Authority, a checklist protocol should be developed utilizing Annex VII of Directive 2006/42/EC to determine if all of the elements of a Technical File contained in A. Points 1, 2 & 3 are compliant. The same could be done for "B. Relevant technical documentation for partly completed machinery." Machinery manufacturers should be asked to provide this information within 48 hours of a request, similar to medical device manufacturers for the Medical Devices Directives.

• Sixth, all manufacturers of machines should be instructed to create the required documentation to comply with the Machinery Directive and Related Directives within a set time period and to make certain that all new machines and modified machines are compliant with the most recent revision of EN standards. (Last year I found three suppliers of Declarations of Incorporation had not updated their products to meet new standards.)

Conclusion

Presently there are tens of thousands of CE Marked machines in the EU market with Technical Files that range from full compliance to incomplete compliance to junk compliance to drivel. Finding out that compliance is a farce and records are a mess, as we discovered in the lawsuit, is unacceptable. I fully support self-certification, but I think it needs to have effective enforcement. As noted in my last blog, I would be happy to work with interested parties, including EU authorities, to improve the quality of EU oversight. I have developed some templates for Checklists and Part A of the Technical File which could be adapted to provide a measure of uniformity to the process that would make it easier for machinery manufacturers to understand compliance and Competent Authorities to determine compliance. 

As noted previously, I would like to work with European manufacturers and companies on steps that can be taken to reduce their liability exposure in the US market. It seems to fit the European philosophical approach to product safety and would help EU firms concerned about the litigious nature of the US marketplace. 

Also, as noted previously I enjoyed working with several colleagues on an Enterprise Risk Management Program for a US medical device manufacturer that had been acquired by a European parent corporation. It was an excellent approach to future planning that I greatly enjoyed. Which is to say, that I think my philosophical sensibilities and interests in risk management are European. If anyone is interested in exploring this topic further, please contact me at jameskolka@gmail.com or jim@jameskolka.com. 

EU Machinery Directive & US Product Liability Lawsuits – A New Era Begins

Introduction

I have written several times about the US product liability implications of the EU Machinery Directive. What makes this blog different is the evolution of EN harmonized standards into ISO and IEC standards and by virtue of ANSI participation drafting ISO and IEC standards, the former EN standards are now also American standards. This fact will have significant implications for future litigation in the US. 

Back-story

In some earlier blogs I described working with an American corporation concerned about the increasing losses from product liability lawsuits and operator deaths in one of their Manufacturing Divisions, losses sufficiently large that they threatened to erase the profits of the division.

Since I had earlier helped another Division in the corporation CE Mark several large exploration and drilling machines, their corporate counsel, vice president and risk manager asked me to examine the litigation history of the Division and give them a report. Reading through their litigation history, it was clear that plaintiffs’ claims focused on allegations of design defects with 60% of claims on defective design, 30% of claims on defective design and manufacturing and 10% of claims on defective manufacturing. Plaintiffs’ attorneys also alleged failure to warn and inadequate instructions (which would come under design) and frequently asked questions about Product Analysis Files.

A review of the manufacturers’ machine design files revealed drawings, schematics, operator/maintenance manuals but no records of the steps that had been taken to design safe machines. Engineering change orders frequently had been made to accommodate customers, but no historical document records of the change orders existed. Operation and maintenance manuals were introduced with titles, “Safety Features” and “Safety Options,” without any realization of the liability exposure created by mentioning “Safety Options” that should never have been optional. In other words, it was a mess. If plaintiffs’ attorneys had any clue about the total lack of any design coherence and meaningful documentation, the litigation results would have been even more devastating. 

Since the manufacturer had CE Marked two machines for placing on the EU Market, I suggested that they use the EU model for all of their machines to address the issue of machinery safety. Corporate counsel and management resisted this approach because they thought it would price their machines out of the US market with their competitors. They asked if they could use US standards such as SAE (Society of Automotive Engineers), ASME (American Society of Mechanical Engineers) and a few industry association standards. In other words, use US standards for machines in the US market and EU standards for machines in the EU market.

I said that could be done, but there are some problems with the approach:

• First, US industry standards tend to be permissive in approach and EU EN harmonized standards are prescriptive in approach. In other words, tougher safety standards in the EU.

• Second, machines models headed to the EU would be meeting higher safety standards than for the US. To knowingly sell a safer machine in the EU and less safe machine in the US could result in significant punitive damages if someone was injured in the US by a less safe machine than was being sold in the EU and that fact was discovered by plaintiffs’ attorneys and the jury.

• Third, if a manufacturer is aware that a higher level of machine safety, the state-of-the-art in the marketplace, and competitors achieving that higher level of safety, a machinery manufacturer is basically is asking for a product liability lawsuit when the less safe machine causes an injury.  

After contemplating their approach to their product liability litigation problem, corporate counsel and management decided to sell the division. While unintentional, I had conducted due diligence. It was cheaper to sell the division rather than correct all of the problems and defend against new product liability lawsuits. Further, their insurance deductable for future lawsuits had just been raised to $2 million dollars per lawsuit.

Concerning the second problem, readers of previous blogs will recall a discussion of a 2002 Minnesota lawsuit where a California manufacturer of packaging machines deliberately omitted a laser light curtain safety device that was required of machines sold in the EU for six years. Consequently, a 28 year old young man working around one of their machines in St. Paul Minnesota walked into an area where the packaging machine was actively moving, was struck in the head and would require 24-hour care for the rest of his life. Had the light curtain been in place, the movement in the area would have been detected by the laser light curtain and shut down the machine. When the jury discovered that the company knew how to make safer machines and was selling them machine in Europe, but decided not to add the safety device to the machine in the United States, they awarded $34 million dollars in punitive damages.

EN ISO Safety Standards and Product Liability Exposure in the US Today

In three blogs posted on March 31, April 30 and May 18 I have related issues regarding a machine that killed a worker in the UK and maimed a worker for life in the US. One of the concerns of the trial attorneys has been the validity of the EN standards used to design and manufacture a machine in a US courtroom. While most of the standards involved in the case were also ISO or IEC standards, a few were EN standards. The possibility existed that defense attorneys might argue that EN standards have no validity in a US courtroom. As noted in my earlier blogs much more obfuscation existed in the “Technical Files” which could be better called “Junk Files.” Yet, the concern existed. Today everyone of the standards involved in that case is now an EN ISO or EN IEC standard. 

For those of you readers who say so what if it’s an ISO or IEC standard, what do International Standards mean in an American courtroom? Read the ANSI web site where you will discover that ANSI is the official US representative to and facilitates US participation in drafting ISO and IEC standards, thereby making them American Standards.

If you still ask so what, read Judge Lisle’s language in a 2000 class action lawsuit where defense attorneys argued that ISO 9001 had no standing in the case. The judge stated, “the Eighth Circuit has consistently held that compliance or noncompliance with ANSI standards is admissible in strict liability and/or negligence cases to prove a design defect.” It should be noted that the other US Circuit Courts Of Appeal have made similar decisions concerning ANSI standards.

Conclusion

The transition of EN Safety Standards is now pretty much complete. Very few safety standards remain that are only EN standards and those will transition to ISO and IEC standards in the near future. If you ask why, the answer is quite simple. All EN. ISO and IEC standards are reviewed approximately every 5 to 7 years to decide whether to retain, modify or eliminate the standard. The EU/European standards authorities CEN and CENELEC agreed to work with ISO and IEC to merge their efforts. ANSI is the American representative in these reviews. Expect to see more ISO, IEC, ANSI standards entering product liability litigation in the future. If you have questions about product liability lawsuits and preventive steps such as product safety/product liability audits to reduce product liability exposure in machinery design and manufacturing, you can contact me at my e-mail address jameskolka@gmail.com.

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

CE Marking Machinery & US Product Liability – The Lawsuits Begin #3

Introduction

This blog is a continuation of two blogs posted on February 25, 2011 and March 31, 2011 respectively. I noted in the second blog my frustration with EU Market Surveillance and the Machinery Directive. I have examined many manufacturers' Machinery Directive Technical Files, some well done and too many done badly.

In spite of early efforts by the European Commission to structure Technical Files into Part A (the index of the file) and Part B (the substance of the file in hardcopy, electronic copy,  samples, etc.) the concept appears never to have gained traction. The virtue of a Technical File divided into two parts with an index is the ability to look at Part A and see if a company attempted to fully comply with the requirements of the Machinery Directive and related Directives.

As a consequence, the mess I have described in the two previous blogs has materialized into a legal case in the UK & US. I have been examining a presumed Technical File that does not contain a comprehensive list of the Directives, Standards and elements required for compliance with the requirements of the Machinery Directive. If I were cynical, I could conclude that the company in question deliberately constructed a “junk file” to cover their tracks in the event of a lawsuit. Or, I might conclude that the personnel who constructed the file were sloppy, indifferent and incompetent. Either conclusion is plausible. 

The only section of the file constructed by the company that purports to resemble a type of index is their EC Declaration of Conformity which is incomplete and inaccurate, e.g. not all standards are cited and several cited are inaccurate, e.g., wrong date of publication, expired or missing. Unfortunately, this pathetic document came to light only after a worker had been killed and another severely injured. These documents should have been reviewed before the manufacturer placed these machines on the EU Market.

Some Ideas for Improving Market Surveillance of the Machinery Directive and Related Directives

While I believe that self-certification can work well and that notified body oversight isn’t necessary, save for exceptional circumstances, I think that there should be a requirement that every manufacturer that places a CE Marked Machine on the EU market should file a document with a member state competent authority that briefly provide the basic elements of the machine which also is shared electronically with the Competent Authorities of all 27 Member States and the European Commission Enterprise and Industry. Further, I think that document should be Part A of their Technical File.

I construct a Part A Technical File for every manufacturer I help to CE Mark their machines.For example, in a recent Part A Technical File developed for a client that recorded the following:

• Annex I Health and Safety Requirements Checklist identifying every essential requirement, the answer (Yes, No, N/A) and if Yes the EN Harmonized Standard(s) that will be used to demonstrate conformity with the requirement  
• EN ISO 14121–1:2007 Safety of machinery – Risk assessment (56 pages written and edited by me and the company’s engineering staff)
• A list of EU Directives – Machinery, Low Voltage, Electromagnetic Compatibility
• A list of 16 EN harmonized standards relevant to the manufacture of this machine
• The overall design, detail drawings and diagrams describing the machine
• Standards calculations
• Guide to the application of the Machinery Directive 2^nd Edition
• EU Compliance Protocol for the machine written by me for my client identifying all of the legal requirements and how they were satisfied
  
• A copy of the EC Declaration of Conformity
• Operating Manual
• Maintenance Manual
• Training Manual
• Sales Materials describing the machine
• Protocol for translating Manuals
• Instructions, Cautions and Warnings
• EC Declaration of Conformity for an electric motor manufactured by another company
• EC Declaration of Conformity for laser equipment manufactured by another company
• IEC System for Conformity Testing and Certification of Electrical Equipment provided by Underwriters Laboratories
• Certificate of Calibration for a machine component
• EC Declaration of Conformity for an Electromagnetic component. 

All of this information was contained in a two-page matrix of 20 items in Part A of a Technical File. Since this was a one-of-a-kind machine, no quality standard was cited. The manufacturer shared this information with their client in the EU as the machine was being constructed. I have provided this level of information for every client with whom I have worked and it is often shared with clients and occasionally member state Competent Authorities. In the case of three different machines being shipped to Turkey where CE Marking was stipulated, the company had to courier all of the CE documents for review by the client company and Turkish national authority for clearance before the ship could be docked and the machines unloaded. I thought this was a fair requirement.

Summary

The only other document that is required for machines to be shipped into the EU is an EC Declaration of Conformity, however it is prepared primarily for customs and, in my opinion, far too cryptic to be useful for the purpose described here. Further, customs officials are far too busy to scrutinize these documents for compliance with the Machinery Directive. In the case of the manufacturer of a deadly machine described in my first two blogs in this series, the only recognizable document in their “junk technical file” was an EC Declaration of Conformity, most notable for what required information wasn’t provided.

Recommendation

In order to exercise some control over the plethora of machines flooding the EU market, I recommend that that the concept of a Technical File with two parts (Part A & Part B) be revived. Further, I recommend that Part A be filed with a legal entity such as a Member State Competent Authority and digitally transmitted to all Member State Competent Authorities and the European Commission, Enterprise and Industry. Part A should include reference to all of the elements required to comply with the requirements of the Directive and related Directives (which will vary for each machine).

Further, I think some type of effort should be made to deal with all of the “junk technical files” for machines already on the market. This could be accomplished in part by citing Decision No. 768/2008/EC of the European Parliament and Of the Council of 9 July 2008 on a common framework for the marketing of products, and repealing Council Decision 93/465/ EEC and requiring every machine to submit Part A for existing machines as well as reminding manufacturers that starting 1 January 2010 they had to comply with revised Directives and revised EN standards.

I would be happy to help with this effort, if there is an interest. In my opinion, the EU Machinery Directive is the most significant contribution to the improvement of machinery safety that has been made. Its ripple effects extend globally to improve machine safety. If you have any questions about the EU machinery Directive and its US product liability implications, you can contact me for a free preliminary consultation at my new e-mail address at jameskolka@gmail.com.

 

 

CE Marking Machinery & US Product Liability – The Lawsuits Begin #2

Legal Issues in the EU and EU Member States

This is a continuation from blog #1 posted on February 25, 2011 concerning a fatal accident in the UK and severe accident in the US involving the same CE Marked machine. This blog focuses on the legal issues and social consequences of the UK fatal accident. A future blog will examine the US product liability implications of the severe accident involving the same CE Marked machine.

As noted in that blog, I have been examining what purports to be a Technical File for a machine manufactured in 2005. In addition to the Technical File being sloppy, seemingly inaccurate and lacking critical details, there appear to be few records retained that can be examined concerning the design the machine, such as the design records for ISO 9001:2000 and series manufacture. 

Because most machines CE Marked for the Machinery Directive are self-certified, Technical Files aren’t examined until something happens, such as an accident. It is only then for the first time that a hodgepodge Technical File materializes to be examined for potential problems. The first governmental agency that examines workplace accidents usually is that country’s equivalent of the US OSHA (Occupational Safety and Health Administration) concerned about workplace safety.

In the UK, that would be HSE (Health and Safety Executive). Only at the next level when CE Mark issues are turned over to the UK agency responsible for the Machinery Directive, BIS (Department for Business Innovation & Skills) is there any technical knowledge of the CE Marking process and Directive requirements, (e.g. Directive Annex I Essential Health and Safety Requirements, EN harmonized standards to demonstrate conformity, Risk Assessment, EC Declaration of Conformity, etc.). Only then are the workplace safety responsibilities of a manufacturer considered vis-à-vis the Machinery Directive.

If this occurs promptly after an accident, in tandem with the HSE investigation, compliance with the Machinery Directive and the CE Mark compliance or noncompliance of the machine will receive consideration on a timely basis. Unfortunately, the fractured Technical File and apparent noncompliance with the requirements of the Machinery Directive and related Directives (Low Voltage Directive and EMC Directive) may be reviewed so late in the process that injured workers and their families may be denied appropriate compensation, time having expired for prompt consideration. It is a perverse Catch 22.

The EU Machinery Directive 98/37/EC in place in 2005 when the machine that caused these accidents was manufactured and the subsequent revised Machinery Directive 2006/42/EC both contain the Article 7 Safeguard Clause that allows for the removal of a CE Marked machine that is not in compliance with the requirements of the Machinery Directive. It states:

1.Where a Member State ascertains that:

--machinery bearing the CE marking, or

--safety components are accompanied by the EC declaration of conformity, used in accordance with their intended purpose are liable to endanger the safety of persons, and, where appropriate domestic animals or property, it shall take all appropriate measures to withdraw such machinery or safety components from the market, to prohibit the placing on the market, putting into service or use thereof to restricted free movements thereof.

Member States shall immediately inform the Commission of any such measure, indicating the reason for its decision and, in particular, whether nonconformity is due to:

(a) failure to satisfy the essential requirements referred to in Article 3;

(b) incorrect applications of these standards referred to in Article 5(2);

(c) shortcomings in the standards themselves referred to in Article 5(2).

3.Where:

-- machinery which does not comply bears the CE marking,

-- a safety component which does not comply is accompanied by an EC declaration of conformity, the competent Member State shall take appropriate action against whom so ever has affixed the marking or drawn up the declaration and shall so inform the Commission and other Member States.

4. The Commission shall ensure that Member States are kept informed of the progress and outcome of this procedure.   

In other words, the Article 7 Safeguard Clause could have been used to remove noncompliant CE marked machines from the EU market. Unfortunately, since no effort was and/or is made to review incomplete, inaccurate or faulty technical files, knowledge to invoke the Article 7 Safeguard Clause would always be “after the fact”. Only if a consumer or more likely a competitor complained about a machine would the Safeguard Clause be used.

Regulation (EC) No 765/2008 setting out the Requirements for Accreditation and Market Surveillance Relating to the Marketing of Products and Repealing Regulation (EEC) 339/93

 The subject matter and scope of the new regulation as set forth in Article 1.

1.This Regulation lays down rules on the organization and operation of the accreditation of conformity assessment bodies performing conformity assessment activities.

2.This Regulation provides a framework for the market surveillance of products to ensure that those products fulfilled requirements providing a high-level protection of public interest, such as health and safety in general and safety in the workplace, the protection of consumers, protection of environment and security.

3.This Regulation provides a framework for controls on products from third countries. [e.g., US, China, Japan, etc.]

 4.This regulation lays down the general principles of the CE marking.

 (As noted in earlier blogs, the implementation date for this new Regulation was 1 January 2010)

Among the initiatives set forth by the new regulation are:

•  Market surveillance measures
  

•  Products presenting a serious risk

•  Restrictive measures

•  Exchange of information – Community Rapid Information System

When EU market authorities find a product that presents a serious risk, they will take measures to prohibit the product from being placed on the market and mark products and documentation with:

•  Dangerous product – release  for free circulation not authorized – Regulation (EC) No 765/2008

When the product is not in conformity with CE marking requirements, the marketing surveillance authority shall require the authorities in charge of external border controls not to release the product for free circulation and market it:

•  Product not in conformity – release for free circulation not authorized – Regulation (EC) No 765/2008

 

Timing & Transparency 

 To date nothing has happened concerning the machine in question and consideration of applying the Article 7 Safeguard Clause to remove it from the marketplace. It may have to move through BIS to and an accreditation authority. The final disposition has not been resolved and the machine and its garbled technical file remain on the market. Clearly, the prospect that a noncompliant machine can only be discovered if a customer complains, a competitor complains or fatal or serious accident occurs is not an acceptable outcome and certainly doesn’t result in improved market surveillance.

I have some ideas to improve supervision of compliance with the Machinery Directive that I will expand upon in my 3rd blog on this topic. I greatly respect the improvement in machine safety already delivered and promised by the EU Machinery Directive and the ambition to improve market surveillance. As a legal consultant, however, it is difficult to persuade US manufacturers to adhere to Directive Requirements if they know of companies treating them lightly, trying to do as little as possible. The legal consequences in the US will be profound! If you have any questions about the EU Machinery Directive and its US product liability legal implications, you can contact me for a free preliminary consultation at my new e-mail address jameskolka@gmail.com

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

CE Marking Machinery & US Product Liability – The Lawsuits Begin #1

Prologue

I have been writing about and working with machinery manufacturers on the EU Machinery Directive since 1991. In 1992, another attorney, Gregory Scott, and I wrote "European Community Product Liability and Product Safety Directives", Published by CEEM Information Services, Fairfax, VA, which included several chapters about the Machinery Safety Directive and Product liability Directive. In 1995, Bruce McIntosh, the Product Safety Manager for Graco, Inc. in Minneapolis, and I wrote "The European Union Machinery Directive: Compliance Manual for Trade", published by Simcom, Inc., Atlanta, GA. In December, 1996 in Washington DC I chaired an American Society for Quality Control Seminar (now the American Society for Quality ASQ), “CE Marking in the U.S.: An Overview”, which reviewed the Machinery Directive with Trade Associations and notified bodies. In 1998, I discussed the legal implications of the Machinery Directive in "ISO 9000… A Legal Perspective", co-published by, ASQ, Milwaukee, WI & Inform, Montclair, VA.

I have been teaching public Seminars on the Machinery Directive since 1992 at the University of Wisconsin, School of Engineering, Madison, WI, Georgia Institute of Technology, Atlanta, GA, Clemson University, Charlotte, NC, Indiana University Purdue University, Indianapolis, IN, QSI Qualified Specialists Inc, Houston, TX and CMTC California Manufacturing Technology Centers, Los Angeles, CA, Ontario, CA & Fresno, CA. I have worked with manufacturing companies CE Marking Machinery throughout the US and Canada, written numerous articles and for the past two years posted 40 blogs on my blog site jameskolka.typepad.com.

Finally, I have worked with numerous manufacturers shipping machinery into the EU requiring a CE Mark (UK, Spain, France, Italy, Germany, the Netherlands, Cyprus, Turkey, etc.) On one occasion I served as legal expert and successfully filed a grievance concerning the legal scope of a Dutch notified body authorization with Commissioner Liikanen and the Machinery Committee of the European Commission. During the past decade, I have served as attorney legal/expert in US product liability lawsuits involving ISO 9001, the Machinery Directive & related Directives, the Medical Devices Directives and FDA’s Quality System Regulation. 

Litigation: US Product Liability, The Machinery Directive & Related Directives

Presently, I am working on litigation in the UK & US concerning a CE Marked machine that has caused a death and severe injury requiring lifetime medical care for operators of a specific machine. A review of the manufacturer’s Technical File or what the manufacturer alleges is a Technical File reveals sloppy and incomplete documentation. It does not contain a Part A index of the File, does not contain an Annex I Essential Requirements Checklist identifying (Yes, No or N/A) answer for each of the essential requirements and does not identify which EN or EN ISO harmonized standards will be used to address the “Yes” marked essential requirements to allow for a presumption of conformity.

While the EC Declaration of Conformity lists EN 1050:1996 as its Risk Assessment standard (it should have been 1997, and given the date of manufacture of the machine in 2005 it should have been EN ISO 14121-1:1999), there is no Risk Assessment following that standard. It appears that the manufacturer assumed that compliance with a C Standard could substitute as the Risk Assessment standard for the machine. I can not! There is no Hazards Analysis/Risk Assessment that would allow for a reasoned determination of Cautions, Warnings and Instructions if hazards could not be designed out or guarded against. This is particularly important in establishing the legitimacy of such language in the US.

The EC Declaration of Conformity listed the Machinery, EMC and Low Voltage Directives, but identified no EMC Standards used for emissions or shielding the machine (nor is there a EMC Certificate from a Competent Body approved test facility identified elsewhere in the Technical File). In addition to listing EN 1050 with the wrong date and not identifying the replacement Risk Assessment standard EN ISO 14121-1:1999, the EC Declaration of Conformity listed EN 12100-1:2001 and EN 12100-2:2001 which for the UK should have been BS EN ISO 12100-1: 2003 and BS EN ISO 12100-2: 2003. Further, reading of the calculations in the file mentions EN 292-1 and EN 292-2, which had been replaced by 2005. (It isn’t clear if the manufacturer simply replaced EN292-1 with BS EN ISO 12100-1 without understanding the substantive changes that had been made.)  As observed earlier, the kindest word for the file would be sloppy. The EC Declaration of Conformity also does identify an Authorized Representative in the EU.                  

Finally, mention is made of ISO 9001 in the body of the file, but not listed in the EC Declaration of Conformity. Since these machines were not “one-of-a-kind”, they would also need to satisfy Annex V, paragraph 3 (b.) for series manufacture, the internal, the internal measures that will be implemented to ensure that the machinery remains in conformity with the provisions of the Directive. Given the 2005 date of the manufacture of the machine, the Quality management System Standard would be BS EN ISO 9001: 2000. This means that the design requirements for the standard should also be examined – 7.3 Design and development, including 7.3.1 Design and development planning, 7.3.2 `Design and development inputs, 7.3.3 Design and development outputs, 7.3.4 Design and development review, 7.3.5 design and development verification, 7.3.6 Design and development validation, and 7.3.7 Control of design and development changes.

ISO 9001: 2000 also has records requirements that could be useful to attorneys wanting to examine the types of steps taken to design the machine. Annex V, paragraph (b) The Documentation referred to in 3 above must be retained and kept available for the competent authority [member state national agency for the Machinery Directive] for at least 10 years following the date of manufacture of the unit produced or of the last unit produced, in the case of series manufacture.

Summary

Thus far I have only discussed some of the issues relevant to the UK and EU. In my next blog, I will expand on additional UK and EU issues and expand the discussion to product liability litigation in the US. Also, remember that this litigation involves a machine manufactured in 2005 and the Directives and Standards current at that time. Since all of the Directives and many of the Standards have been revised, the machine and the accidents would be approached differently at this time. However, new EU Regulations now exist that could be invoked at this time. I will discuss these issues in my next blog and a third blog will discuss EU regulatory compliance and the US product liability implications of the EU Machinery Directive in 2011 – they are not the same thing. If you have questions about the EU Machinery Directive and its US product liability legal implications, you can contact me for a free preliminary consultation at my new e-mail address jameskolka@gmail.com.

CE Machinery Malpractice: “The Whole Machine Must Be Greater Than The Sum Of Its Parts!” #2

Introduction  

In my July 31 blog #1, I discussed US companies combining drive systems, such as a generator mounted on a flatbed truck attached to partly completed machines such as a drilling rig or an excavator, then declaring the combination “Voila” to be a complete machine. It is a lazy way to CE Mark a machine and it is a form of malpractice. I’m sure manufacturers in other third countries (the EU term for all countries outside the EU) are doing the same thing, however, it is illegal. This blog is going to explore this issue in greater depth, using the Guide to application of the Machinery Directive 2006/42/EC, 2^nd Edition, June 2010, General Editor, Ian Fraser published by the European Commission Enterprise and Industry.  

Machinery Directive Definitions  

Article 2, Definitions States, “For the purposes of this Directive, ‘machinery’ designates the products listed in Article 1 (1)(a) to (f).   The following definitions shall apply:  

-- an assembly, fitted with or intended to be fitted with a drive system other than directly applied human or animal effort, consisting of linked parts or components, at least one of which moves, and which are joined together for a specific application,  

-- an assembly referred to in the first indent, missing only the components to connect it on site or to sources of energy and motion,  

-- an assembly referred to in the first and second indents, ready to be installed and able to function as it stands only if mounted on a means of transport, or installed in a building or structure,  

(g)’partly completed machinery’ means an assembly which is almost machinery but which cannot in itself perform a complete a specific application. A drive system is partly completed machinery. Partly completed machinery is only intended to be incorporated into or assembled with other machinery or other partly completed machinery or equipment, thereby forming machinery to which this Directive applies.  

The Problem  

There are companies that manufacture partly completed machinery such as drilling rigs and excavators that claim to have CE Marked their equipment before being connected to a drive system, such as a generator, which isn’t legally possible. Instead, they must issue a Declaration of Incorporation. As noted in the June 2010 Guide Section  

§18 However, the manufacturer of partly completed machinery must state, in a Declaration of Incorporation, which of the essential health and safety requirements he has fulfilled – see §385: comments on Annex II 1 B, and §394: comments on Annex VII, B.  

In addition, the June 2010 Guide states:  

For machinery to be supplied without a drive system:  

-- the manufacturer’s risk assessment must take into account all the risks associated with the machinery, including those relating to the drive system to be fitted to the machinery – see §158: comments on General Principle 1 of Annex I;  

-- the machinery manufacturer must set out in his instructions all the necessary specifications for the drive system to be fitted such as the type, power and means of connection, and provide precise fitting instructions for the drive system – see §264: comments on section 1.7.4.2 (i) of Annex I;  

-- the conformity assessment of the machinery must cover the specifications of the drive system to be fitted and the fitting instructions ;  

-- the CE-Marking on the machinery and the EC Declaration of Conformity that accompanies the machinery must cover the specifications and instructions relating to the drive system to be fitted.  

§ 37 Machinery to be installed on a specific support  

The third indent of the definition of machinery refers to machinery intended for installation on a means of transport or in a building or structure.  

If such machinery is mounted on road vehicles or trailers that are excluded from the scope of the Machinery Directive, the requirements of the Machinery Directive do not apply to the vehicle or the trailer itself, however the requirements of the Machinery Directive apply both to the mounted machinery and to all aspects of the interface between the machinery and the chassis on which it is mounted which may affect the safe travel and operation of the machinery.  

The third indent of the definition of machinery implies that the manufacturer of machinery intended to be installed on a means of transport or installed in a building or structure is responsible for the conformity of the machinery with the relevant health or safety requirements. He must affix the CE-marking on the machinery and draw up and sign the EC Declaration of Conformity. The manufacturer of such machinery must take into account in his risk assessment all the risks associated with the machine, including those relating to installation of the machinery on the chassis of a vehicle or trailer or an a supporting structure. (Emphasis added)  

Manufacturers of machinery intended to be installed on a means of transport must therefore specify the vehicles or trailers on which such machinery can be safely installed, either by reference to their technical characteristics or, were necessary to specific models of vehicle.  

The conformity assessment of machinery intended to be installed on a means of transport or in a building or structure covers the machinery itself, the specifications for the supporting structure and the installation instructions. The necessary tests and inspections must be carried out on the machinery installed on its support in order to check the conformity with the essential health and safety requirements. The CE-marking on the machine and the EC Declaration of Conformity that must accompany the machine cover the conformity itself and the specifications and instructions relating to its installation. (Emphasis added)  

What Does All of this Mean? 

The manufacturer of CE Marked machinery mounted on a means of transport is responsible for the conformity of the machinery with the Machinery Directive Annex I Essential Health and Safety Requirements applicable to the complete assembly and the Final Risk Assessment taking into account all of the risks associated with the machine, including those relating to the installation of the machinery on the chassis of a vehicle or trailer; including the partly completed drill rig or excavator and the partly completed generator.  

Both partly completed machines should have documents detailing what Annex I Essential Health and Safety Requirements apply to their partly completed machines, the EN standards that allow for a presumption of conformity, an ISO 14121-1:2007 Risk Assessment and an EC Declaration of Incorporation. The generator also should demonstrate how it satisfies the revised Electromagnetic Compatibility Directive 2004/108/EC, the CE Marking Directive 2000/14/EC of 8 May 2000 relating to the noise emission in the environment by equipment for use outdoors and EU Directive 2004/26/EC relating to measures against the emission of gaseous and particulate pollutants from internal combustion engines to be installed in non-road mobile machinery.  

Legal Implications of CE Marking Machinery Malpractice  

Market Surveillance – The revised Machinery Directive in …”The ninth and tenth recitals introduce several provisions in the new Machinery Directive which establish a stronger legal basis for market surveillance and enforcement action.”  

Product Safety Directive – The revised EU Product Safety Directive 2001/95/EC strengthened the requirement that “products placed on the market are safe”  

US Product Liability Exposure – Any US Machinery manufacturer who places a machine on the EU market can be sued for cause in a US District Court for failing to manufacture a safe machine, i.e. one that complies with the safety requirements of the EU Machinery Directive. While this may seem a little far-fetched, I have served as legal expert in lawsuits filed in a US District Court by European Companies against American manufacturers. The rationale is quite simple, since European Courts do not encourage product liability lawsuits and US Courts are receptive to product liability lawsuits and the two parties meet the legal requirements to sue in a US Court, then why not use US law to seek monetary relief? Expect an increase in such lawsuits in the future. If you have product liability concerns regarding the Machinery Directive & related Directives, you can contact me for a free preliminary consultation at theguide1@comcast.net

Brussels You Have a Problem! – Out Of Date CE Marked Components & EC Declarations Of Conformity – Machinery #2

Introduction  

The first blog of this title identified the problem of out of date CE Marked Components and EC Declarations of Conformity, EC Declarations of Incorporation and EN Standards. Presumably, 1 January 2010 marked the date when CE Marked products must contain the latest revised EU Directives and latest EN harmonized standards. It is now six months later. As noted in my first blog on this topic, I discovered that component suppliers to my customers have been lax on this account. Not only have they not updated their EC Declarations of Conformity, EC Declarations of Incorporation and EN harmonized standards, in far too many cases they are out of synch by several years. This is a technical problem and potentially serious legal problem for component suppliers and their customers in both the EU and US. It also is extremely lazy and sloppy.  

Machinery Directive Market Surveillance  

I concluded the first blog in this set with a brief reference to provisions that were inserted into the Machinery Directive to improve market surveillance when the Directive was adopted in 2006. Below you will find those three provisions from the prior blog followed by several other provisions set forth in the revised Machinery Directive which are now supposed to be in force:  

·      Monitor conformity of machines with the relevant Directives  

·      Empower authorities to take action with necessary speed to remove machines from the EU market  

·      Fix rules concerning legal sanctions for non-compliance  

·      Organize surveillance activities to cover all stages of a machine lifecycle (placing on the market, use, withdrawal including recovery, recycling and destruction)  

·      Record and ensure the follow-up of complaints or reports concerning non-compliant machines  

·      Monitor accidents and damage to health concerning machines on the market  

·      Implement market surveillance programs for categories of machines and categories of risk  

·      Carry out checks of conformity of machines on the market  

·      Require the necessary documents and information for machines on the market

·      Where relevant, sample machines and subject them to the necessary inspections and tests  

·      Initiate the relevant infringement procedures for non-compliant machines  

·      Ensure that machines comply with the essential requirements of the relevant Directives  

·      Exchange market surveillance information with member states  

·      Develop joint member state projects for market surveillance  

·      Survey machines on the market to assure that CE marking and documentation requirements have been met and that machines have been designed and manufactured in accordance with the essential requirements of the relevant directives and don’t present any danger to personnel  

·      Create rapid and confidential exchange of information where machines could present a serious and immediate risk to the public interest  

·      Increase involvement of the machine manufacturer in the procedure  

·      Check for documents (essential requirements checklists, technical data, EN harmonized standards, risk analyses, notes, certificates of conformity, etc.)  

·      Physically examine machines, check on the presence of CE marking, other markings and possible regulatory labels  

·      Physically check on the name and address of the manufacturer and/or the person responsible for placing the machine on the market (authorized representative)  

·      Physically check for undue or incorrect CE marking or other regulatory marking

·      Where necessary, conduct laboratory tests to determine the conformity of the machine with the essential requirements of the relevant Directives  

·      Use robust practices to detect serious cases of non-conformity and the probability of risk  

·      Ensure effective communication and coordination between market surveillance activities and other organizations that intervene in the field of safety of machines (health and safety at work authorities and customs authorities)  

·      Provide for the rapid exchange of consumer machine information   ·      Implement EU Regulation 339/93 on the conformity of machines imported from third countries (now replaced by Regulation 765/2008)  

·      Take account of data concerning industrial accidents involving machines  

·      Link with the EU General Product Safety Directive  

·      Develop member state legal sanctions for non-compliant machines  

·      Improve administrative cooperation between EU member states for non-compliant machines  

·      Strengthen rules for worker safety and worker reporting on machines improperly CE marked  

Summary  

These are excellent steps and can’t be put in place soon enough. For those of us who take machinery safety seriously, enforcement of the rules would help us convince our clients in the US and other third countries that the EU is serious about machinery safety. Given the number of fly-by-night & bait-and-switch consultants filling the web pages with easy CE assurances and simple templates telling manufacturers that it won’t cost anything to CE Mark their products, serious enforcement can’t come fast enough.

The EU is unique in their systematic approach to product safety, and machinery safety in particular. Except for those products and machines covered by FDA, we have no comparable regulatory approach in the US. I would like to believe that US manufacturers share the EU belief in machinery safety (and some do share that belief), but I know better from personal experience.

Many clients have complained that safety increases the price of machines and makes them less competitive in the US market. I remind them of the 2002 Minnesota lawsuit where a US machinery manufacturer made a safe machine for the EU to satisfy CE Marking standards and a less safe machine for the US and paid the price in a $35 million punitive damages award to the plaintiff in a product liability lawsuit. Unfortunately, this fact doesn’t impress companies willing to take a risk, even if it harms people. Their question is, can I come up with an alternative?

I would love to work with the EU in improving their market surveillance and the hope for residual carryover to the US. As the world no doubt knows by now, antipathy to regulation runs high in the US (witness the US Materials Management Service paper mâché regulation of offshore drilling). Apparently, only catastrophe changes minds. If you have any questions concerning compliance and product liability vis-à-vis the revised Machinery Directive, you can contact me for a free preliminary consultation at theguide1@comcast.net.

Brussels You Have a Problem! – Out Of Date CE Marked Components & EC Declarations Of Conformity #1

During the past few months I have worked with three clients preparing their CE Marking compliance materials (Applicable Directives, Annex I Checklist, Applicable EN Standards, Legal Protocol, Technical File, ISO 14121-1 Risk Assessment, identification of a Authorized Representative), for placing their machines on the market in the EU. In each case these clients purchased CE Marked Components for parts of their machines and received EC Declarations of Conformity from the component suppliers. All well and good!  

On closer examination, however, I noticed that one of the EC Declarations of Conformity for a part purchased in 2009, was dated November 2003 and listed four BS EN Standards dated 1997, 1994, 1999 & 1993. Out of curiosity I went to the BSI website and entered the numbers and titles of the standards. Three had been replaced in 2001. Only the 1994 standard was current. When contacted, the component supplier said, you purchased the component last year, ignoring the fact that three standards cited were even out of date when the Declaration was signed in 2003. My client was assured that the component satisfied the requirements of the 2001 standards, after some additional work by the components manufacturer.  

Another EC Declaration of Conformity from the supplier of a key component had to update 10 EMC & Low Voltage EN Standards that had been replaced by a more recent version of the standard. Only three of the standards remained the same. In this case, the recent versions of the standards had been used to manufacture the component, but the EC Declaration of Conformity had never been updated to reflect the changes.  

Following these two discoveries, I examined four other EC Declarations of Conformity for three clients and found all four to contain EN standards that had been replaced by a more recent version. To see if this same phenomena existed elsewhere, I called a client I will be working with in August and asked if he had received a Declaration of Incorporation for a machinery part we will be adding to his machine. He sent the Declaration to me and it too was out of date. The world of CE Marking compliance and market surveillance may have been tightened on 1 January 2010, but you couldn’t tell that from these component suppliers.  

Finally, I received a call from another client concerning CE Marking electrical components for the revised Low Voltage Directive. On one web site a components supplier listed compliance with a 1981 EN Standard. When I looked up the standard on the web, I found that the standard did not exist. It was so old that any connection to an existing replacement standard was lost, yet the company’s electrical components were proudly listed as CE Marked on their website. Further, the company somewhat sanctimoniously noted that they complied with the Low Voltage Directive 72/23/EEC as amended by 93/68/EEC. There was no mention that the new EU Low Voltage Directive 2006/95/EC repealed the prior Directive as of 16 January 2007. Clearly this supplier was and is out of date.

Some of these suppliers are American, some are multi-national and some are European. All were sloppy and somewhat peeved to have their shortcomings called to their attention. While my sample of 10 suppliers is small, I suspect that the failure to update may be widespread, if not endemic. Worse yet, these suppliers were not aware of the EU Regulation 765/2008 designed to tighten EU market surveillance. (For an expanded discussion of the regulation, see my October 30, 2009 blog.) 

Regulation (EC) No 765/2008 Setting out the Requirements for Accreditation and Market Surveillance Relating to The Marketing of Products and Repealing Regulation (EEC) No 339/93  

Presently, I want to underscore some additional aspects of the Market Surveillance measures of Regulation (EEC) No 339/93:  

·      Market surveillance measures – Article 19 (1.) Market surveillance authorities shall perform appropriate checks and, where appropriate, physical and laboratory checks on the basis of adequate samples. When doing so they shall take account of established principles of risk assessment, complaints and other information.  

·      Products presenting a serious risk – Article 20 (1.) Member states shall ensure that products which present a serious risk requiring rapid intervention, including a serious risk the effects of which are not immediate, are recalled, withdrawn or that their being made available on the market is prohibited, and that the Commission is informed without delay thereof, in accordance with Article 22.  

·      Restrictive measures – Article 21 (1.) Member states shall ensure that any measures taken, pursuant to the relevant Community harmonization legislation, to prohibit or restrict the products being made available on the market, to withdraw it from the market or to recall it, is proportionate and states the exact grounds on which it is based.  

·      Exchange of information – Community Rapid Information System – Article 22 (2.) If a product presenting a serious risk has been made available on the market, Member States shall notify the Commission of any voluntary measures taken and communicated by economic operators.  

·      Controls of products entering the Community market – Article 27 (3.) The authorities in charge of external border controls shall suspend release of a product for free circulation on the Community market when any of the following findings are made in the course of the checks (on the characteristics of products)  

o   The product displays characteristics which give cause to believe that the product, when properly installed, presents a serious risk to health, safety, the environment or any other public interest  

o   The product is not accompanied by written or electronic documentation required by the relevant Community harmonization or is not marked in accordance with that legislation  

o   The CE marking has been affixed to the product in a false or misleading manner  

·      The authorities in charge of external border controls shall immediately notify the market surveillance authorities of any such suspension  

When The EU market authorities find a product that presents a serious risk, they will take measures to prohibit the product from being placed on the market and mark the products documentation with:  

‘Dangerous product – release for free circulation not authorized – Regulation (EC) No 765/2008.   When the product is not in conformity with CE marking requirements the market surveillance authorities shall require the authorities in charge of external border controls not to release the product for free circulation mark it:

‘Product not in conformity – release for free circulation not authorized – Regulation (EC) No 765/2008  

Summary  

In addition to being incredibly lazy and sloppy, I consider the problem of out of date EC Declarations of Conformity and EN harmonized standards to be quite serious. It has safety and liability implications for both the seller and buyer in the EU and US. It also is an area where machinery manufacturers do not expect to receive out of date components.  As of 1 January 2010 only revised Directives and the newest version of EN harmonized standards are to be identified on CE Marking Documents such as the EC Declaration of Conformity.  

When the revised Machinery Directive was adopted 2006, several provisions were inserted to improve market surveillance, such as:  

>Monitor conformity of machines with the relevant Directives  

>Empower authorities to take action necessary to remove non-compliant machines from the EU market  

>Fix rules concerning legal sanctions for non-compliance  

These are just a few of the new rules. I will expand the list in a future blog. If you have any questions concerning compliance and product liability questions concerning the revised Machinery Directive, you can contact me for a free preliminary consultation at theguide1@comcast.net.

CE Marking Products for the EU – Product Liability Exposure in the US

I have discussed the topic of product liability exposure in several of my 2009 blogs. Recently, however, as I was helping a client find a company to make new metal plates with a CE Mark, company name and serial numbers for his machines, I came across advertisements from numerous consultants declaring that they could help companies CE Mark their products for modest amounts of money. Of course these claims often are understated only to have the client discover that it will cost a great deal more to finish the work, another form of “bait and switch.” And in other ads, manufacturers pursuing the lowest possible cost discover that they are buying a series of “fill-in-the-blank” templates, which are “one size fits all” for machines ranging from simple to complex. Both approaches could be categorized as a form of fraud.  

Caveat Emptor (Let the Buyer Beware!)

While Americans are suckers for anything cheap, “CE Marking Lite” for machines is a bad idea for several reasons. To comply with the revised Machinery Directive, it is necessary to identify the appropriate conformity assessment procedure for your machine and/or machine product family; it is necessary to construct an Annex I Checklist; identify the relevant EN harmonized standards that will allow the manufacturer to demonstrate a presumption of conformity with the Essential Requirements; it is necessary to conduct a complete ISO 14121-1: 2007 Risk Assessment and Hazards Analysis with documentation; create a Part A Technical File and EC Declaration of Conformity.  

The legal steps taken to comply with the EU revised Machinery Directive and related Directives should be clearly spelled out in your documentation so that the legal rationale and path taken is clearly written in a document for EU member state competent (national) authorities. In addition, this documentation will be vital to a legal defense in the event of a product liability lawsuit in a US Court of Law. This latter point also underscores the liability exposure for any EU based consultants in the UK, Ireland, the Netherlands, France, etc. working directly or via the internet in the EU with EU, US and other third country clients.  

If an EU based consultant or consulting firm accepts money from a US based company for CE Marking Assistance, they are subject to US Law in US Federal and State Courts. The fact that these consultants are physically based in the EU is irrelevant, because they are doing business in the US.  

Issues That Must Be Addressed When Complying with the Machinery Directive and Related Directives  

The primary focus of the Machinery Directive and other new approach Directives is product safety and in the case of machinery, machinery safety. To this end the Annex I Essential Health and Safety Requirements (ESHSR) were designed to address the various aspects of machine safety. This also means that new designs must incorporate the elements of the ESHER into the design of new machines and modify the designs of existing machines accordingly.  

To do this, it is necessary to identify the EN harmonized standards that will allow for a presumption of conformity. Many of these EN harmonized standards have been revised and are now EN ISO standards which means as ISO standards they also are American Standards, since the American National Standards Institute (ANSI) participates in the drafting of ISO standards (the implications of ANSI participation will become more apparent in future product liability litigation, see my July 10, 2009 & March 23, 2009 blogs). In short, ANSI standards are acceptable evidence to establish state-of-the-art in product safety in US Courts of Law.  

I have worked with machines from simple to extremely complex. The number of EN harmonized standards can range from as few as four to 30 or more. It depends on the number of ESHSR that apply to a specific machine. To assert that the certification for simple to complex machines can be handled for US$730.00 is not only absurd, it is wildly misleading. Further, it is necessary for each machine to conduct a hazards analysis and risk assessment for the design of the machine. To suggest that all hazards analyses and risk assessments are equal and can be handled for the same amount of money is equally stupid and misleading. A competent risk assessment can take a significant amount of time to do well. The more complex the machine, the greater amount of time and detail.  

Compliance with ISO 14121-1: 2007 Safety of machinery – Risk assessment – Part 1: Principles. Conducting a thorough risk assessment means that every possible hazard is identified and the reduction of that hazard to an acceptable level of machine safety by designing out all hazards, guarding against those hazards that can’t be designed out or guarded against and creating warnings and instructions for those hazards that can’t be designed out or guarded against.  

Every single question in the risk assessment standard must be answered Yes, No or N/A and the answer must be written in clear English so that it can be understood if a product safety issue arises. In most instances questions will arise several years later after the original writers of the risk assessment have moved on to other positions or retired. Therefore, the answers will have to stand on their own.  

Finally, it is only at the end of this process that a manufacturer can establish warnings and instructions for a machine and to determine how the machine should be marked for machine safety. Failure to issue warnings without conducting a full hazards analysis and risk assessment has resulted in punitive damage awards for plaintiffs against numerous manufacturers in product liability lawsuits in the US.  

Summary  

Product liability exposure will increase with the revised Machinery Directive, related Directives and the revised EN ISO standards. All companies, (domestic and foreign manufacturers, independent consultants and notified body consultants) active in the US marketplace will be subject to product liability exposure (see my July 10, 2009 blog, CE Marking Machinery – Future State-of-the-Art in American Product Liability Lawsuits). CE Marking will assume greater importance as soon as plaintiffs’ attorneys and subsequently defense attorneys begin to understand what is happening.  

While the one case to date that went to trial in Minnesota in 2002 resulting in a $35 million dollar punitive damages judgment involved safety standards, it was understood by the jury as a case where a California machinery manufacturer had been making a safer machine for the EU and a less safe machine for the US resulting in an injury that crushed the skull of a worker requiring 24 hour care for the rest of his life. The attorneys and the jury didn’t know that California machinery manufacturer implemented safety standards created for the EU Machinery Directive. What the jury did know was the fact that the California machinery manufacturer knew how to make a safer machine and had been doing so for 6 years, but chose to make a less safe machine for the US Market.  

How does this affect future product liability litigation in the US? Quite simple, a plaintiff’s attorney hires someone like me to serve as a legal expert to testify about the CE Marking process and how your company failed to meet the Directive’s Essential Health and Safety Requirements resulting in an injury to the attorney’s client or clients. It is similar to my involvement as a legal expert in product liability, design and contract litigation involving ISO 9001.  

Presently I am talking with some attorneys about serving as legal expert concerning accidents involving US manufactured machines. I discovered that two of the manufacturers sell their machines in the EU, which means that their EU machines should be CE Marked. Therefore, the question arises, are the EU machines safer? A perusal of their Technical Files, compliance with EU harmonized standards and hazards analysis/risk assessment will provide valuable information for the lawsuit. If you have product liability and risk assessment concerns vis-à-vis the US market regarding the revised Machinery Safety Directive and related Directives, you can contact me for a free preliminary consultation at theguide1@comcast.net.  

CE Marking Cosmetics & Pharmaceutical Machinery Starting 1 January 2010

Introduction 

I have just finished working with two clients CE Marking machines for the UK, Italy, Spain, Cyprus and Israel and will begin working with a client who wants to comply with the legal requirements of the Directive on Cosmetic Products and the Directive on Medicinal Products for Human Use which raises some interesting questions. While it may not be apparent, Cosmetics and Pharmaceuticals intersect with machinery in an interesting way in the revised Machinery Directive 2006/42/EC, namely in the Annex I Essential Health and Safety Requirements, Section 2.1 Foodstuffs Machinery and Machinery for Cosmetics or Pharmaceutical Products.  

The basic language of the revised Machinery Directive is straightforward:  

“Machinery intended for use with foodstuffs or with cosmetics or pharmaceutical products must be designed and constructed in such a way as to avoid any risk of infection, sickness or contagion.”  

The following requirements must be observed:  

(a) materials in contact with or intended to come into contact with, foodstuffs or cosmetics or pharmaceutical products must satisfy the condition set down in the relevant Directives. The machinery must be designed and constructed in such a way that these materials can be cleaned before each use. Where this is not possible disposable parts must be used.

Conceptually, the expanded rules parallel FDA’s authorization under the Federal Food, Drug and Cosmetics Act, which has now been expanded to include tobacco. The big difference, however, is the focus here is on the machinery that manufactures foodstuffs, cosmetics and pharmaceuticals, whereas FDA’s focus is on the manufacturing of  these products. FDA doesn’t prescribe how to build machines, but they will inspect manufacturing processes to see if they are satisfying FDA’s Good Manufacturing Practices.  

Manufacturing Cosmetics and Pharmaceutical Products in the EU  

Prior to 1 January 2010 cosmetics and pharmaceutical machines had to be CE Marked to be used in manufacturing cosmetic and pharmaceutical products. This meant, however, that they only had to satisfy Section 1 Essential Health And Safety Requirements of Annex I of the Machinery Directive. Starting on 1 January 2010, under the revised Machinery Directive, cosmetic and pharmaceutical machines must also satisfy Section 1and Section 2 Supplementary Essential Health And Safety Requirements For Certain Categories of Machinery and Section 2.1 Foodstuffs Machinery And Machinery For Cosmetics Or Pharmaceutical Products. This means these machines now have to meet additional requirements, “to avoid any risk of infection, sickness or contagion”  

“The following requirements must be observed:”  

(a) materials in contact with or intended to come into contact with, foodstuffs, or cosmetics or pharmaceutical products must satisfy the conditions set down in the relevant Directives. The machinery must be designed and constructed in such a way that these materials can be cleaned before each use. Where this is not possible disposable parts must be used.  

(b) all surfaces in contact with foodstuffs or cosmetics or pharmaceutical products other than the surfaces of disposable parts, must:  

--be smooth and have neither ridges nor crevices which could harbor organic materials. The same applies to their joinings,  

--be designed and constructed in such a way as to reduce the projections, edges and recesses of assemblies to a minimum,  

--be easily cleaned and disinfected, where necessary after removing easily dismantled parts; the inside surfaces must have curves with a radius sufficient to allow thorough cleaning;  

(c) it must be possible for liquids, gases and aerosols deriving from foodstuffs, cosmetics or pharmaceutical products as well as from cleaning, disinfecting and rinsing fluids to be completely discharged from the machinery (if possible in a cleaning position);  

--(d) machinery must be designed and constructed in such a way as to prevent any substances or living creatures, in particular insects, from entering or any organic matter from accumulating in, areas that canny be cleaned;  

--(e) machinery must be designed and constructed in such a way that no ancillary substances hazardous to health, including the lubricants used can come into contact with foodstuffs, cosmetics or pharmaceutical products. Where necessary, machinery must be designed and constructed in such a way that continuing compliance with this requirement can be checked.  

Instructions  

The instructions for foodstuffs machinery and machinery for use with cosmetics, pharmaceutical products must indicate recommended products and methods for cleaning, disinfecting and rinsing, not only for easily accessible areas but also for areas to which access is impossible or inadvisable.  

How this will be enforced is not yet clear to me, but I have no doubt that it will be enforced. The EU is ramping up its market surveillance activities this year. To a degree, this falls into the same category as the new requirements for medical device machines having to satisfy both the Medical Devices and Machinery Directive. Also, the Cosmetics Directive is being revised with an expectation that the revised Directive will be published later this year. I expect some association with the new machinery requirements will be made in the revised Directive. I also expect greater emphasis on the  EN ISO 14121-1: 2007 Safety of Machinery Risk Assessment Standard to assure compliance,as well as other EN standards on basic Hygiene of food, cosmetics and pharmaceutical products.

What About the US And Third Countries?  

This new requirement to CE Mark machines should not only apply to EU manufactured foodstuffs, cosmetics and pharmaceutical products, but all foodstuffs, cosmetics and pharmaceutical products manufactured in third countries and placed by those companies on the EU market. This would apply to companies in the Third Countries like the US, Canada, Brazil, China, Australia, India, etc.  

Just as FDA will inspect any manufacturing facility in the world to make certain that they are satisfying FDA Health and Safety Good Manufacturing Practices before exporting to the US, I anticipate that the EU will develop a means to accomplish the same Health and Safety objectives about exporting into the EU. Therefore, this means that companies in the US should now be preparing their foodstuffs, cosmetics and pharmaceutical products in CE Marked machines to satisfy, EU Health and Safety Requirements. If you have any questions regarding the new Machinery Directive requirements for Foodstuffs, Cosmetics or Pharmaceutical Products, you can contact me for a free preliminary consultation at theguide1@comcast.net.