People bearing responsibility for the CE compliance of products placed in the EU zone are, as follows:
- authorised representatives.
Manufacturers of products that fall under the scope of one or more of the CE directives have the following legal obligations:
- carry out the conformity assessment
- create the technical documentation, also knows as 'technical file'
- issue the Declaration of Conformity
- affix the CE mark to the product.
If you are a distributor of products requiring CE marking, then you must check if the CE mark is present, along with the user manual, product label and any other necessary supporting documentation.
All importers of products from countries outside the EU/EEA have the responsibility to check if the manufacturer has undertaken all necessary steps, as well as if the technical documentation is available. However, if you import a product but place it in the EU market under your own (brand) name, then you have the same obligations as the manufacturer.
The responsibilities of the authorised representatives are limited to:
- holding the technical documentation and Declaration of Conformity for ten years after the product has been placed on the market
- being able to comply with any requests for information regarding the product’s compliance.