3. CE marking


CE marking

Standing for Conformité Européenne, the CE marking is a pictogram affixed to the device by the manufacturer to indicate/declare that it conforms to all applicable EU regulations.

Figure 2. The 'Conformité Européenne' CE mark and dimensions.

However, watch out - the CE mark should not be confused with the ‘China Export’ symbol Figure 3 shown below.

Figure 3. The 'China Export' CE symbol.

Medical Devices belonging to the lowest risk class, class I, do not have to be certified by a Notified Body before they can be CE marked, unless the Medical Devices include sterile products, a measuring function or reusable surgical instruments. 


[1] European Commission. Notified Bodies. https://ec.europa.eu/growth/single-market/goods/building-blocks/notified-bodies_en


When a Notified Body issues the CE certificate, the manufacturer still has the full responsibility for continuously complying with the requirements of the CE marking and thus qualifying for the certificate.

Medical Devices must be re-certified regularly, and the Notified Body is responsible for assessing the manufacturer's documentation. Before the certificate expires, the manufacturer must submit a new application for continued certification to the Notified Body. The Notified Body will audit whether the manufacturer has continuously updated the documentation for the product and complies with the legal requirements before a new certificate is issued. The review of the documentation must take place at least every five years to ensure the device is still safe and works as intended. 

After a Medical Device has undergone its initial CE marking process (the Conformity assessment) there is a separate ‘market access’ process in which the value of the device is assessed to determine if it is worth purchasing and using under real life conditions.