The CE mark is required for a product in order to:
- show that the manufacturer has checked that the product meet EU safety, health or environmental requirements
- provide an indicator of a product’s compliance with EU legislation
- allow the free movement of products within the European market
The inclusion of the CE mark on a product represents the manufacturer’s declaration, on their sole responsibility, that the product conforms with all of the legal requirements to achieve CE marking. The manufacturer is thus ensuring validity for that product to be sold throughout the EEA. This also applies to products made in third countries which are sold in the EEA and Turkey.
Not all products must bear the CE marking. Only those product categories subject to specific directives that provide for the CE marking are required to be CE marked. A CE Mark must be applicable to all Medical Devices and Medical Products
A CE mark is not intended to denote that a product was made in the EEA, but states that the product is assessed before being placed on the market in the EEA. It means the product satisfies the legislative (safety and efficacy) requirements to be sold in the EEA and that the manufacturer has checked that the product complies with all relevant essential requirements, for example health and safety requirements.
Manufacturers are responsible for ensuring they:
- carry out the conformity assessment
- set up the technical file
- issue the EC Declaration of Conformity (DoC)
- place CE marking on a product
Distributors of Medical Devices must check the presence of both the CE marking and the necessary supporting documentation and ensure that the manufacturing site (particularly if it is outside the EU) has undertaken the necessary steps to comply with the CE requirements.