Introduction
I just completed a CE Marking project for a client. In the process I once again encountered a small CE Marked machine that my client wanted to include to provide mobility for his CE Marked machine. When we asked for the EC Declaration of Conformity, the manufacturer in the EU seemed to be perplexed by our request. We needed to make certain that the CE Mark was current, listed the most recent EN harmonized standards, listed EN 12100: 2010 (Incorporating corrigendum January 2011) Safety of machinery – General Principles for Design – Risk Assessment and Risk Reduction and was RoHS compliant. I also asked if their ISO 9001 certification was ISO 9001: 2008. The ISO 9001 standard was current, but instead of an EC Declaration of Conformity they sent a copy of a “Certificate of Adequacy.”
At first I thought it was a joke, but discovered that such certificates existed at one time. I also discovered that the Certificate of Adequacy model was cancelled with the adoption of the new Machinery Directive MD 2006/42/2006 that came into force on the 29th of December 2009. The company that sent the Certificate of Adequacy listed eight models in the Product Family on the Certificate but had made no changes in the models since the Certificate was issued and clearly knew nothing about being RoHS compliant. The UK Notified Body that had issued the Certificate had not alerted the company of the need to update its information, use current EN harmonized standards, comply with the RoHS Directive and create a current EC Declaration of Conformity. This meant that a large number of non-compliant machines had been CE Marked for several years and sold to customers in the EU and elsewhere in the world.
The Problem
This wasn’t the first time I have encountered improperly and/or non-compliant CE Marked products in the marketplace and undoubtedly will not be the last. In the US, however, product liability lawsuits and non-compliant machines can result in significant financial losses for companies where the non-compliance results in injuries to people and property. The first time I encountered a bogus CE Mark accompanied by a bogus certificate was several years ago when I reviewed the paperwork submitted by a Dutch notified body to a client that had lost several product liability lawsuits in the US. I was asked by corporate counsel to examine the causes of the lawsuits and report my findings.
I discovered that the manufacturer had invited a team from a Dutch notified body to travel to my client’s plant in the US. The notified body issued a report identifying several machines that it stated could not be CE Marked without changes. They also issued two EC Type Examination Certificates for two machines that they said could be CE Marked. Since the notified body was only notified for Annex IV (Dangerous Machines) and neither of these machines remotely qualified for Annex IV these two EC Type Examination Certificates were bogus and had no value for my client in a US Federal District Court. The notified body had acted as a consultant, charged notified body fees and failed to inform my client of their status. I first attempted to contact the notified body with the help of the UK Department of Trade and Industry DTI (now the Department of Business Innovation and Skills BIS).
The notified body refused to respond to numerous DTI inquiries. DTI suggested that I try to contact them directly. After six months of no response, I contacted the Dutch Competent Authority, the oversight body for Dutch notified bodies. Again no response, so I decided to contact European Commissioner Likanen of Directorate General III Enterprise and Industry and relate my frustrations accompanied by e-mails and correspondence sent by me to DTI, the Dutch notified body and the Dutch Competent Authority. After three weeks I received an e-mail from the Machinery Committee of DG III that said that my interpretation that the two EC Type Examination Certificates were invalid was correct. Both the Dutch notified body and Dutch Competent Authority were copied on this correspondence.
It was clear at the time that the Dutch notified body team felt empowered to play fast and lose with the Directive, enjoy an all expenses paid trip to Atlanta and bill a manufacturer that knew nothing about the Machinery Directive. At the very least it was a breach of ethics and potential product liability exposure in a US District Court if the machines had caused an injury. Recall that this particular manufacturer already had lost several product liability lawsuits.
When I saw the Certificate of Adequacy sent to my client two months ago, my first reaction, was another scam. At the very least the manufacturer of the machine my client wanted to use to transport his machine, had a Certificate that was meaningless issued years ago by a UK notified body that didn’t inform their prior client that the Machinery Directive had been revised and their Certificate of Adequacy was void, that the EN standards cited on the certificate might be out of date and a new standard (RoHS) was now required.
Component Suppliers
Over the past four years I have worked with several US Manufacturers who have opted to buy CE Marked Components to use when building a CE Marked machine. It’s a wise move and will reduce the amount of testing required for their machine. The only catch is the validity of the Component CE Mark. I have contacted several Component suppliers pointing out that their EC Declaration of Conformity was out of date. In at least two instances the component was a critical element of a machine that was going to be placed in a secure location in an EU member state. If the machine failed because of the component, my client could face serious legal action in the member state and a product liability lawsuit in a US District Court.
Remember that a US CE Marked machine manufacturer can be sued by a EU buyer in a US District Court if the damages sought meet US Federal monetary requirement. Likewise an EU CE Marked machine manufacturer can be sued by an American buyer if the damages sought meet US Federal monetary requirements. CE Marked machine manufacturers have already been sued successfully in US Courts. The cross-pond litigation has only just begun.
Conclusion
The EC Declaration of Conformity should accompany every CE Marked product. That it too often has to be pried out of a manufacturer of CE Marked products is more than irritating, it is an immediate cause for suspicion. My immediate assumption is that a failure to provide an EC Declaration of Conformity is duplicity, the manufacturer has something to hide. It is a reason to ask for Part A of the Technical File to see if the manufacturer is trying to hide something. A month ago I told a US buyer of a number of CE Marked products that he should insist on the EC Declaration of Conformity and Part A of the Technical File or seek another manufacturer. Unfortunately, I have seen too many efforts to obfuscate information and have become a bit cynical about manufacturer efforts to hide critical information.
I will continue a discussion of some of these issues in future blogs. My primary focus is on International Regulatory Compliance, which includes 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 Court or state courts. I focus on product safety, product liability and the steps necessary to create a safe product and serve as Legal Expert/Expert Witness where safety has been compromised or ignored resulting in damage and/or injury. If you have questions regarding ISO 9001, FDA’s Quality System Regulation or CE Marking lawsuits you can contact me for a free preliminary consultation at my e-mail address jameskolka@gmail.com
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