Misunderstanding the CE mark

Reducing potential liability and increasing quality assurance with electrical industrial/laboratory equipment

One day, a great idea comes to you. Your mind is made up, your idea is churning, and senior leadership has given you the blessing required to move forward. As the weeks and months pass, your designs are coming together. You choose components from an approved vendors list and were told that everything should be CE marked. What the CE mark means may be somewhat vague, but you reassure yourself, “that’s what every other product has, and so will mine”.  You are not alone. This type of thinking towards regulatory and its associated marks of conformity is very common.

Although sale of a product globally is the goal, we will focus on the two major markets in this article. The requirements for North America as well as the European Economic Area. In North America there is a Nationally Recognized Testing Laboratory (NRTL) mark of conformity and in the European Economic Area there is a CE mark (self-certification).

Before we jump into the differences between the CE mark and the NRTL mark, lets step back and explain the basic hierarchy of global regulations. “The difference between directives/laws and standards” .

Most every major global market has Essential Requirements that outline what manufacturers must do before selling a product in that region. These are the basic laws that detail how products must be designed in order to confirm they are safe and free from reasonably foreseeable hazards.

As an example; in the United States, there are requirements within the Code of Federal Regulations (CFR) which highlight how a products safety should be verified and what organizations can help in that process. On the other hand; the member states of the European Economic Area have agreed to accept the same essential requirements for easier sales in the region. These regionally accepted essential requirements are known as Directives. Put simply, essential requirements usually require proof of a safe product as well as proof of a quality system in order to maintain the safety of the product over its lifetime.

In order to show compliance to the essential requirements (i.e. Directives and Laws), we must have technical data and an organized technical file (or Design History File) which documents all designs, risks and mitigation utilized for compliance. The technical data is generated based on the applicable safety standards. Safety standards translate the essential requirements into actionable tests and inspections, which if passed, will prove compliance to the essential requirements.

Each major global market usually has their own regional standards for compliance. For example, the United States accepts Underwriters Laboratory (UL) standards, Canada accepts Canadian Standards Association (CSA) standards, and Europe accepts European Standards (EN). Before you start tracking down all the regional standards, you should really focus on what are known as globally harmonized standards. These are developed by the International Electrotechnical Commission (IEC). Most major global markets will accept an IEC standard in place of their local standards due to the fact that many nations around the world are part of the IEC scheme group and have input into their creation.

Now that we understand the essential requirements, as well as the requirements for a technical file and its subsequent need for the proper safety standards, we can talk about the difference between certification marks on the product itself. These certification marks simply tell a customer what type of regulatory you have done on the product, and what they can expect to see inside the technical file.

Most CE marks are provided as self-certification (unless you fall into certain product classes like Medical Devices, which require a Notified Body Review – a topic for another day). The term “self-certification” means that the manufacturer has solely declared that their product meets all necessary regulations within the European Economic Area (the CE mark is only applicable to this region). To support this claim, the manufacturer can either test and evaluate the product to the necessary safety standards in-house, or in cooperation with a third-party laboratory. Although continued review of the product SHOULD be documented within the quality process, it is not usually verified by anyone. This is why the deliverables associated with the CE mark can drastically vary depending on the due diligence of each manufacturer. (Authors note: As someone in the industry, I have yet to see a single CE mark/technical file done 100% correctly)

An NRTL mark of conformity (i.e. ETL, TUV, CSA, UL) is designated for the North American markets only. The Occupational Safety and Health Administration (OSHA) and the Federal Communications Commission (FCC) are the governing bodies for the US but their authority is also accepted within Canada.  These two organizations give an NRTL its legal authority through rigorous audits and certification programs. Thus, by placing an NRTL mark on the product the manufacturer proves to customers that not only does it comply with North American essential requirements through the evaluation of safety standards, but that the NRTL reviews the product on a quarterly basis in order to maintain continued compliance. This is a key benefit of the NRTL mark since the essential requirements change every few years. This audit or feedback loop provides another level of assurance to customers. Although the NRTL mark is not technically recognized in other global markets outside of North America, the continual product audits that come along with the NRTL mark do meet some of the essential requirements for other nations. In comparison a company that self certifies for EEA (CE mark), may not have this reoccurring and detailed product audit.

It should be noted that many other global markets, such as Mexico (NOM), Korea (KCC), Russia (EAC) etc, have their own local mark of conformity. Many times, no additional testing is required to receive these global marks, but instead, a review of the products technical file and application of globally harmonized standards (IEC) is required. Also, be aware of the scope of these marks, as they do not apply to all products. If this is the case with your product, you may have to show compliance through other options laid out by the essential requirements for that country. It does not mean however that no regulatory requirements are applicable.

Author: Brett

Brett Gagnon is currently one of the global subject matter expert for electrical equipment and electrical medical devices at Merck KGaA Darmstadt Germany, otherwise known as Millipore Sigma within North America. He has an Electrical Engineering degree from Wentworth Institute of Technology and a Masters of Business from Southern New Hampshire University. Mr Gagnon has a background in the ATIC (Assurance Testing Inspection Certification) industry based on previous years working for Intertek Testing Services NA Inc out of the Boston Ma area. During his time at Intertek he became a CB certified engineer evaluating products to medical, laboratory, IT, and Industrial standards. He also has a knowledge base in laser, Ingress Protection testing and wireless radio registration. Additionally Mr. Gagnon was a Field label and Special Inspection agent reviewing large custom equipment for national safety approvals in North America.

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