The CE marking rules typically require the following steps to be fulfilled before the CE mark may be affixed:
- Determine the applicable CE directives/regulations;
- Identify the applicable European harmonized standards;
- Identify which essential requirements of the CE marking directive/regulations apply to the product;
- Identify which requirements of the European harmonized standards apply to the product;
- Conduct and document the conformity assessment against the essential requirements and the requirements from the standards (this may entail visual inspection, testing etc.);
- For some products (f.e. machinery and medical devices) a risk analysis shall be conducted;
- Provide the user with the information required to use the product safely (typically user manual, installation instructions, warning labels, etc.);
- Ensure consistency of production, thus proving the assessed sample and the production are identical;
- Compile a Technical File (or sometimes called “technical documentation”) of all documents that are necessary to show compliance with all relevant requirements;
- Draw up and sign a Declaration of Conformity (for construction products a Declaration of Performance);
- Affix the CE mark or another conformity marking if relevant;
- Continuously monitor developments related to CE directives/regulations and European harmonized standards. Apply new rules and amendments where appropriate.
This is a general description of the process, and particular CE regulations may require additional steps.