Product Integrity
CE Marks are seen everywhere, from the iPhone through to silicone tubing used in medical devices (as one of our clients manufactures). It can be a complex issue, knowing if your products should be CE Marked, and how to go about doing it. Episode will guide you through the process.
Related Standards
BS EN 1090
In the UK it is a legal requirement that any structural metalwork is CE marked under the Construction Products Regulations (CPR)
ISO 13485
Compliance to laws in quality management systems in medical devices.
Incorporating MDD/MDR
The letters ‘CE’ and logo shown below appear on many products that are traded on the single market in the European Economic Area (EEA).
The letters "CE" are the abbreviation of French phrase "Conformité Européene" which means "European Conformity".
The CE marking is required for many products. It:
- shows that the manufacturer has checked that these products meet EU safety, health or environmental requirements
- is an indicator of a product’s compliance with EU legislation
- allows the free movement of products within the European market
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:
- carry out the conformity assessment
- set up the technical file
- issue the EC Declaration of Conformity (DoC)
- place CE marking on a product
If you are a distributor you must check the presence of both the CE marking and the necessary supporting documentation.