Incorporating MDD/MDR
The letters "CE" are the abbreviation of French phrase "Conformité Européene" which means "European Conformity".
The CE marking is required for many products. It:
For certain categories of products, such as medical devices and structural metalwork, not only do you have to conform to the requirements summarised below, you also have to have independent certification of conformance carried out (by companies known as notification bodies). These bodies are authorised by national authorities and officially ‘notified’ to the European Commission and listed on the NANDO (New Approach Notified and Designated Organisations) database .
By placing the CE marking on a product you are declaring, on your sole responsibility, conformity with all of the legal requirements to achieve CE marking. By doing this you are 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, so if you have product manufactured outside of the EEA or Turkey you must CE Mark them. This will include rigorous controls you put in place to ensure your manufacturing partner does things correctly. .
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 (see
CE marking does not mean that a product was made in the EEA, but states that the product is assessed before being placed on the market. It means the product satisfies the legislative requirements to be sold there. It means that the manufacturer has checked that the product complies with all relevant essential requirements, for example health and safety requirements.
If you are a manufacturer it is your responsibility to:
If you are a distributor you must check the presence of both the CE marking and the necessary supporting documentation.