The answer of course is YES! Until recently, I didn’t think the question needed to be asked or answered anymore. Much to my surprise, however, I continue to work with manufacturers who have sold non CE Marked products to EU customers seemingly oblivious to this fact. In some cases EU customers have told US manufacturers not to worry, they (the customer) will take care of it. In other cases I have been told that their EU customer orders had been placed directly with the US manufacturer therefore they (the US manufacturer) reasoned that a CE Mark wasn’t necessary. However, now that they wanted to ship to distributors in the EU, they (the US manufacturer) figured that the products had to be CE Marked. Both assumptions are inaccurate.
Twenty years have passed since I first worked with a manufacturer in Connecticut who was told by an EU buyer (Siemens) that they wanted to buy their machines, but they had to be CE Marked. Among other things I am an attorney, fully aware that all new approach directive products have to be CE Marked. No EU buyer can say they will take care of it! The legal liability for placing non CE Marked products on the EU market falls entirely on the manufacturer, distributor, etc. placing a product on the EU market, not the buyer of that product. This applies to all manufacturers, be they US, EU, Australian, Japanese, etc. This means that the legal liability for placing non CE Marked products on the EU market falls on the manufacturer, distributer, etc. As in the US legal system, Ignorance of the law is no excuse! Presently, there are 28 EU Member States in the EU and 4 affiliated states
Where else is a CE Mark required?
By now most manufacturers are aware that nations anticipating joining the EU, such as Turkey, require CE Marks on products placed on their markets. The nations of the former European Economic Area EEA, Norway, Iceland, Liechtenstein, Switzerland also participate in the CE Marking protocol. In addition, future EU member states likely will include Serbia, Macedonia, Montenegro, Bosnia and Herzegovina and Kosovo and possibly Albania. In addition, an increasing number of buyers in other countries, such as Russia, Israel, South Africa and even China have required CE Marking on their products. In these instances CE Marking is a purchaser requirement.
How Do You Know If The CE Mark is Current?
To begin, with a CE Marked product you should receive an EC Declaration of Conformity. It must contain the Directives and EN Standards complied with to put CE on a product. The EN harmonized standards should be current. In other words, the most recent revision available when the product was manufactured. Understandably some small products such as Low Voltage circuits might not have an EC Declaration of Conformity, but a call to the company should direct you to a website or a telephone number where you can obtain the needed information. For most products the EC Declaration should accompany the product. I have seen EC Declarations that were a complete farce, contained little useful information that were involved in a lawsuit.
The same issue applies to CE Marked components that are used in products such as a CE Marked machine. It is critical that manufacturers know the date of the EN harmonized standards used in a component used in a machine. A few years ago I worked with a manufacturer of a machine that was going to be used in a secure location. First I discovered that three component manufacturers hadn’t supplied EC Declarations of Conformity and when we received the Declarations they were over four years old and did not reflect current EN standards revisions. In some cases significant changes had been made.
When we called the component manufacturers they were peeved at even having to consider the question and when we said these machines were going into secure areas they still didn’t see the gravity of our situation. Ultimately when we said we would have to purchase from other manufacturers they relented and updated their components and provided current EC Declarations of Conformity.
As a buyer or representative of a buyer of CE Marked products I like to see Part A of a Technical File, an index of all the elements relevant to the manufacture of the machine. Below you will find an excerpt from one of my previous Blogs. Personally, I would not purchase a machine without having this information.
The Machinery Directive Technical File
Directive 2006/42/EC of 17 May 2006 on Machinery, and amending Directive 95/16/2006 (recast) (the revised Machinery Directive) sets forth the requirements of the Technical File in Annex III.
A. Technical file for machinery
This part describes the procedure for compiling a technical file. The technical file must demonstrate that the machinery complies with the requirements of this Directive. It must cover the design, manufacture and operation of the machinery to the extent necessary for this assessment. The technical file must be compiled in one or more official Community languages, except for the instructions for the machinery, for which the special provisions of Annex I, section 126.96.36.199 shall apply.
1.The Technical file shall comprise the following:
(a) a construction file including:
--a general description of the machinery,
--the overall drawing of the machinery and drawings over 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 machinery with the essential health and safety requirements, this is
--the documentation or risk assessment demonstrating 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 and, when appropriate, the indication of the residual risks associated with machinery.
--the standards and other technical specifications used indicating 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 via body chosen by the manufacturer or his authorized representative,
--a copy of the instructions for the machinery,
--where appropriate, the declaration of the incorporation for included partly completed machinery and the relevant assembly instructions for such machinery,
--a copy of the declaration of conformity.
(b) for series manufacturer, the internal measures that will be implemented to ensure that the machinery remains in conformity with the provisions of this directive.
The manufacturer must carry out necessary research and tests on components, fittings on the completed machinery to determine whether by its design or construction is capable of being assembled and put into service safely. The relevant records and result 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 and for at least 10 years following the date of manufacture of the machinery or, in the case of serious manufacturer, oval last unit produced.
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.
The technical file does not have to include detailed plans for any other specific information as regards the sub-assemblies used for the manufacture of machinery unless a knowledge of them is essential for verification of conformity with the essential health and safety requirements.
3. Failure to present the technical file 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 performance.
In 1993 The European Commission proposed that national authorities divide the Technical File into two parts: Part A (frequently called the thin file) and B (frequently called the thick file).
Part A consists of a summary of the essential technical data relevant to the conformity assessment procedures, including:
- the name and address of the manufacturer and the identification of the product;
- the list of the essential health and safety requirements (Annex I) that apply to the product(s) and the list of the harmonized standards followed b the manufacturer and/or the solutions adopted to satisfy the essential safety requirements;
- a description of the product;
- the operating instructions, if any; and
- the overall plan of the product, if any
Basically, Part A is an index of the items in the Technical File. Part B is the full file that is kept at the manufacturer’s site. If needed, national authorities can demand greater portions of the full file technical file to conduct an inspection. In the instances cited above where Customs asked for Part A of the file. I also include an Annex I Checklist with the EN harmonized standards used to demonstrate compliance with the Essential Health and Safety Requirements. I am an attorney and I believe that full documentation is essential.
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 email@example.com