CE and CE Mark Process

What is CE?

“CE” is a certification mark that informs conformity of a product according to health, safety and environmental standards, so a manufacturer can easily sell products within the European internal market i.e. European Economic Area.

More details on "CE" you can find on my previous blog;
"CE Marking".

LED bulb with CE Mark

CE Full Form

CE full form is, “Conformité Européenne”, which means European Conformity.

CE Mark

The CE Mark on a product is the product manufacturer's announcement or declaration that the product fits the necessitate of the relevant EC directives.

The CE Mark consists of a logo, “CE”. Some times it consists of a Notified Body’s four digit identification number, who is engaged in the conformity assessment activity.

CE Logo

CE Marking Process

Below steps will clear CE Marking Process, subjecting to your product and the risk criteria associated with it;

• First step is to search and find the directives related to your product. If there are more directives for the same product then please follow and comply all those related directives.
• In the applicable directives, find the level up to which your product observes or follows the important necessities required for design and manufacturing.
• There are numerous modules available for the Conformity Assessment Procedures as listed below, select the conformity assessment procedure from the below options i.e. modules according to the directive for your product.

Module A: Internal production control - It covers the design and production stages. This module does not need the intervention of any advised body.

Module Aa: Intervention of a Notified Body.

Module B: EC type-examination - It includes the design phase, and need be monitored or followed by a module needed for assessment in the production stage. An "EC type-examination" certificate is issued by a notified or advised body.

Module C: Conformity to type - It includes the production stage and follows module B. It offers the conformity by the type as defined in the EC type-examination certificate allotted conferring to module B. Module C does not need the intervention or involvement of a notified or reporting body.

Module D: Production quality assurance - It includes the production stage and follows module B. It originates from the quality assurance standard EN ISO 9002, by the involvement of a notified body, which is liable for approving and monitoring the quality system for; production, final product inspection and testing setup by the manufacturer.

Module E: Product quality assurance - It includes the production stage and follows module B. It originates from quality assurance standard EN ISO 9003, by the involvement of a notified body, which is liable for approving and monitoring the quality system for; production, final product inspection and testing setup by the manufacturer.

Module F: Product verification - It includes the production stage and follows module B. A notified body controls conformity to this type as defined in the EC type examination certificate allotted according to module B. It assigns a certificate of conformity to the product.

Module G: Unit verification – It includes the design and production stages. Every single product is inspected by a notified body, and this notified body issues a certificate of conformity.

Module H: Full quality assurance - It includes the design and production stages. It originates from quality assurance standard EN ISO 9001, with the involvement of a notified body which is responsible for approving and regulating the quality system for design, final product inspection and testing setup of the product.

The selected directives frequently use a sequence of queries about the scope or nature of your product to categorize the level of risk or hazard and mention to a chart called "Conformity Assessment Procedures", which contains all the possibilities accessible to a product manufacturer to certify their product and fix the CE Mark.

CE Mark on a Multimeter

There are two types of products at certification process;

Minimal Risk Products

A manufacturer can prepare a Declaration of Conformity and use CE mark as a self-certification on their product in the case the products falls in Minimal Risk criteria’s.

Greater Risk Products

Following points to be consider for products which have greater risks;

• As per the respective directives these types of products to be certified by a “Notified Body” or as mentioned in the directive.
• “Notified Bodies” are certified test labs and follows all the test procedures mentioned in the directives. They are approved by the government and follow the laws of European Commission. After approval by the government they work as autonomous test labs. These types of labs may be owned by government or by private sectors.  Whoever owns the lab, but they have to follow testing requirements as mentioned in the directives and should meet all the pre-defined criteria’s mentioned in the directives and laws.
• Product manufacturers may choose a testing agency in any European Union state.
• Details of these testing agencies or notified bodies can be find from European Commission’s official journal.
• These notified bodies identify the standards needed for testing of a product.
• These notified bodies perform tests on the product according to standards.
• These notified bodies issues test certificate to the product.
• These notified bodied evaluate or cross-check the submitted product testing files from product manufacturer.

Steps to get CE Certification from a Notified Body

Below steps will clear the CE marking process to get certification from Notified body;

• First step is to identify the correct directive related to our product.
• Next select a Notified Body, which have facility to test or examine our product.
• For your product find an Official Representative in the European Union. This representative will help to prepare the Technical file or Documentation as per the directive.
• Next step is to prepare a Declaration of Conformity. It contains details about the directives and standards which confirms your product, identification details of your product. It also contains name, address and signature of the manufacturer. This declaration will help to trace the product back to the manufacturer or the official representative in the European Union.
• Next you have to register your product in European Union i.e. to get Certificate of Registration. Without this the products are not permitted to fix CE Mark and to place in the market. This is mostly with Class I Medical Devices.
• At the last fix the CE Mark to your product. According to Council Directive 93/68/EEC fix the CE Mark on the product. This directive contains specific instruction for the fixing of CE Mark on the product i.e. instructions addressing the size and position of the Marking; fixing the CE Marking to products, packing and documents to be ship with the product and detailed restrictions on when and who is allowed to fix the CE Mark.

Correct CE Mark

Now let discuss about CE Technical File or Technical Documentation, which is very important part for product approval from Notified Body.

What is CE Technical File and What is CE technical file requirements?

CE Technical File

• It contains all the information that confirms that the testing was performed correctly and that the product complies with appropriate standards.
• It should be prepared by manufacturer or by Representative (as per directive).
• It is necessary as, it delivers information on the design and manufacturing stages of the product.
• The particulars comprised in the documentation depend on the type of the product and demonstrates the conformity of the product to the critical necessities of the applicable directive.

CE Technical File Requirements

The following points to be consider for the CE technical file requirements;

• Overall description of the product.
• General drawing of a product. Should also include design and manufacturing related drawings, components diagrams, diagram of sub-assemblies, and schematic of control circuits. Descriptions and clarifications should be there to understand these drawings, schematics and figures.
• For hazards related to products, should include risk study or analysis along with detail method to eliminate hazard in that product.
• Important necessities of the product related directives.
• Should include the information of standards, which are used for the testing or analysis of the product.
• Design related calculations.
• Test reports and certificates of used components (can be arrange from the component manufacturers).
• Instructions for product use.

Example of Certificate of Compliance

Conclusion

When a product manufacturer affix the CE Mark on a product it indicates that it complies with all the necessary Health and safety necessitate. Also, it confirms that the product is according to all relevant directives and ready to sell in European market. The process to get CE Mark for a product from a notified body is not very complicated, you have to properly follow the process and full fill all CE technical file requirements according to relevant directives.