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THE CE MARKING

A European mark of conformity

What is the CE mark? Why do you need it? How do you get it? Do you need a notified body? Conformity assessment procedures?

The CE marking was created within the framework of the European technical harmonization legislation. It is the visible commitment of the manufacturer that his product respects the regulatory requirements for its free circulation on the whole territory of the European Union.

The CE mark must be affixed to many products before they can be sold in the EU. It indicates that a product has been assessed by the manufacturer and found to comply with EU requirements for safety, health and environmental protection requirements.

CE marking is mandatory for all products covered by one or more European regulations (directives or regulations) that explicitly provide for it.

To date, some twenty regulatory texts for technical harmonization (directives or regulations) provide for the affixing of the CE marking, covering vast categories of products. Only products covered by these texts must bear the "CE" marking.

The Regulation on Personal Protective Equipment (PPE) is Regulation (EU) 2016/425. You can consult it by clicking on the link below.

Regulation (EU) 2016/425

If you are a manufacturer, or a legal representative of a manufacturer, you must follow these 6 steps to affix a CE marking on your product

1- Identify the applicable directive(s) and harmonized standards
2- Check the specific requirements of the product
3- Determine if an independent conformity assessment (by a notified body) is necessary
4- Test the product and verify its conformity
5- Establish and maintain the required technical documentation
6- Affix the CE marking and draw up the EU declaration of conformity

For products with higher safety risks, the safety cannot be checked by the manufacturer alone. In these cases, an independent body, in particular a notified body designated by the national authorities, must carry out the safety authorities, must carry out the safety check. The manufacturer can only affix the CE marking to the product once this check has been carried out.

If your product does not have to be checked by an independent body, you must ensure that it complies with the technical requirements. In particular, you must assess the potential risks associated with the use of the product and report them.

Manufacturers of category II and III PPE must go through a notified body in order to be able to affix the CE mark to their products.

Aliénor Certification is a notified body N°2754 that can provide you with CE certification services for your PPE.

Request a quote

The conformity assessment of products is generally carried out in two stages, which relate to the design phase of the product and its manufacturing phase.

4 types of evaluation procedures (or "modules") are applicable to PPE depending on their category:
- Module A: For PPE category I
- Module B: For PPE category II and III
- Module C and C2: For PPE category III
- Module D: For PPE category III

Aliénor Certification is notified to carry out module B and module C2.

Module B Module C2
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