I first wrote about this issue in my June 10 & June 16, 2010 Blogs “Brussels You Have a Problem! – Out of Date CE Marked Components & EC Declarations of Conformity – Machinery.” Unfortunately, the problem persists and either the indifference or arrogance of component suppliers appears not to have changed. It is especially vexing when you know that the buyer will not and should not accept machinery with components made with dated standards, in particular machines that are delicate, unique and are tasked with new applications where performance and security are critical to the buyer. Poor performance because of out of date standards would be costly and potentially disastrous.
The same performance standards would be expected from medical machines, not just new medical machines. Machine failure could jeopardize patient health and safety and result in costly litigation that could and should double back and bite the maker of component parts. Indifference to the consequences of sloppy parts manufacturing that could negatively impact the manufacturer of machines tasked with delicate and potentially risky applications is unacceptable and incompetent.
In my most immediate encounter with component parts made with outdated standards, a UK component manufacturer’s Electrotechnical division stated that the CE mark was affixed in 1997, 17 years ago. The EC Declaration of Conformity listed two Electromagnetic Compatibility standards for emission and immunity, one dated 1992 and the other listing no date. Both standards have been Superseded, Withdrawn and Replaced by standards dated 1999 and 2001. The third standard addressing safety requirements for electronic equipment for measurement, control and laboratory use was also Revised, Withdrawn and replaced by a 2010 standard. The entire EC Declaration of Conformity was woefully out of date and yet was sold as a legitimate EC Declaration of Conformity for a component sold to my client.
Another EC Declaration of Conformity issued by a California company also was woefully out of date. It identified two EMC standards for immunity and emissions dated 2001. The present edition of these EMC standards published by the European commission identified both standards most recent date as 2007. Again my clients were sold a component part that was out of date. I could go on identifying other components that were dated and sold within the past few months.
This sounds like the type of complaint levied against Chinese manufacturers for not paying attention to EU manufacturing requirements. Instead, these electronic components were sold either by EU or US component manufacturers who simply were not keeping their products up-to-date with current EN standards. Worse yet, when my clients called to complain and ask for replacements they were hassled for even asking their questions. Clearly, the component manufacturing sectors need to upgrade their internal processes so that their customers receive the best possible products and services or they should quit the business.
In my prior two blogs I mentioned EU regulations designed to tighten EU market surveillance. One of those regulations was 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
At that time in 2000 I went on to underscore some additional aspects of the Market Surveillance in Regulation(EC) No 765/2008.
Market surveillance measures – Article 19 (1.) Market surveillance authorities shall perform appropriate checks and were 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 they’re 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 the products)
- The product displays characteristics which can cause to believe that a product, when properly installed, presents a serious risk to health, safety, the environment or any other public interest
- The product is not accompanied by a written or electronic documentation required by the relevant Community harmonization or is not marked in accordance with that legislation
- 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 product’s 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 authority shall require the authorities in charge of external border controls not to release the product for free circulation and mark it:
‘Product not in conformity – release for free circulation not authorized – Regulation (EC) No 765/2008
As noted in my earlier summary, I consider the problem of out of date EC Declarations of Conformity and out of date EN harmonized standards to be a serious matter. It has safety and liability implications for both the supplier and manufacturer in the EU and the 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 EU Directives and the newest version of EN harmonized standards are to be identified in CE Marking Documents such as the EC Declaration of Conformity. I also would add that the EC Declarations of Conformity are supposed to list the relevant Directives for a product and the relevant EN harmonized standards including the dates of those standards. Too many of the electronic Component Declarations of Conformity that I have been reviewing are sloppy, cryptic and do not contain the required information. The arrogance and indifference of these component suppliers is not acceptable.
Finally, I would remind the suppliers of Component Parts that a faulty part, whether it is supplied by a US, EU or any other country is subject to US product liability law if that part would cause a machine or any other product to fail and injure a US citizen. The component manufacturer can be brought into a US court and subjected to a product liability lawsuit. All that is required is one-party either be American citizen or company and the amount of money meet the monetary requirements to initiate litigation. This works both ways. Any non-US citizen or company injured by an American product or component part that would cause injury to a non-US citizen or company likewise can avail themselves of the US legal system and initiate a product liability lawsuit. It is an expensive way to correct indifference or incompetence, but it does work!
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. I also serve as Legal Expert/Expert Witness where safety has been compromised or ignored resulting in damage, injury and or death. If you have questions regarding ISO 9001, ISO 13485, FDA’s Quality System Regulation or CE Marking lawsuits you can contact me for a free preliminary consultation at my e-mail address firstname.lastname@example.org