CE Marking vs. CE Certified? Are These The Same or Different?
A CE Marking, as seen above, is a mark placed on a product that claims compliance and conformity to the applicable CE Marking Directives and Regulations. CE Marking Directives and Regulations are in place to ensure that the respective products are safe for users and the environment. Most products and equipment are required to have a CE Marking to be sold in the countries of the European Union.
The CE Marking assessment procedure is usually based upon self-certification by the product manufacturer. However, in some cases, an assessment from an EU Notified Body is required. While an EU Notified Body may be involved, the responsibility of ensuring compliance lies firmly with the manufacturer. Due to the complexity of the CE Marking process and applicable Directives and Regulations, many manufacturers will consult with an EU Notified Body, such as Technology International, to ensure they are guided through the process correctly and are in compliance with European Union law.
The compliance of a product is completely under the control of the manufacturer. By signing the EU Declaration of Conformity, the manufacturer is making a legal declaration to the governments of all 27 EU countries that they have identified all applicable EU product legislation and that the product conforms fully to all of those laws.
What Is CE Certification?
The short answer is there is no such thing. It’s a misnomer. There is only CE Marking. Some folk in the US who aren’t familiar with CE Marking assume it is a certification process and therefore call it CE Certification. That’s all. If you don’t want your European customers getting snooty and looking down their nose at you, we advise you call it CE marking!!!
But are there any CE Certificates?
Within a narrow technical aspect of CE marking there is a certificate-producing process called “EU Type Examination” (in certain legacy cases “EC Type Examination” is still used). As you can imagine, a successful exam result results in an exam certificate. But be very clear, an EU Type Exam certificate is NOT a Declaration of Conformity. It is an incredibly strong bit of evidence that supports your Declaration, but that is all it is: supporting evidence. An EU Type Exam can only be conducted by an EU notified body.
A Notified Body is an organization accredited by an EU country to the European Commission to assess the conformity of certain products before being placed on the market. These organizations are audited and accredited every year and are held to the highest standards. In the USA, accreditation is managed by NIST on behalf of the European Commission under the EU-USA Mutual Recognition Agreement, and audited by ANAB and A2LA.
This process is not required for the majority of products. When required in the relevant law, the CE Marking to be affixed to the product must be accompanied by the certifying Notified Body’s identification number. For example, there are no Type Examinations possible for any product under the Low Voltage Directive, Under the Machinery Directive and EMC Directive all Type Examinations are voluntary, but the vast majority of products subject to the Radio Equipment Directive require Type Examination.
Do not get concerned about Type Examination and certificates. Talk with your CE advisor and understand which laws apply to your product and what the specific requirements are of those laws. Unless you are working in a highly regulated area, such as radio, high pressure equipment or medical equipment etc, the likelihood is that you will have no need of Type Examination.
EU Blue Guide
The EU Blue Guide [1] is a general guide to CE Marking. It is the closest thing in plain language to explaining CE marking, but please understand it does not carry any legal weight itself, and has no legal authority. The individual law has authority in all cases. explains that there are many different routes to compliance. The guide gives a very good general overview of the broad principles of CE Marking. Each individual law specifies exactly how it works, and what modules may or may not be available.
Generally speaking, there are eight different modules for CE Certification. The modules are named A-H and indicate the responsibilities of the manufacturer and the degree of involvement of the in-house accredited or EU Notified Body. The modules are as follows.
Module A: Internal Production Control – this module covers both design and production.
Module B: EU-Type Examination – this module covers design.
Module C: Conformity to EU-Type Based on Internal Product Control – this module covers production and follows Module B.
Module D: Conformity to EU-Type Based on Quality Assurance of the Production Process – this module covers production and follows Module B.
Module E: Quality Assurance of Final Product Inspection & Testing – this module covers production and follows Module B.
Module F: Conformity to EU-Type Based on Product Verification this module covers production and follows Module B.
Module G: Conformity based on Unit Verification – this module covers both design and production.
Module H: Conformity Based on Full Quality Assurance – this module covers both design and production.
The vast majority of CE marking follows Module A.
Seek Advice From CE Experts
The CE Marking process can be very complex and have many requirements. It’s critical to assess requirements carefully in order to determine your obligations and to ensure the correct Conformity Assessment path is taken. Technology International can help you make the correct determinations and guide you through the entire CE Marking Process to ensure your products can be sold in the European Union.
[1] https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=OJ%3AC%3A2016%3A272%3ATOC
[2] https://ec.europa.eu/growth/tools-databases/nando/index.cfm?fuseaction=country.main