The CE marking is affixed to a medical device as a symbol that the product is in conformity with the regulations. The manufacturer must carry out a conformity assessment and document that the essential requirements have been met before the device can be CE marked. It is not permitted to use the CE marking on a device that is not in conformity with the regulations.
Devices that shall not bear the CE marking:
- Custom made devices
- Investigational devices
- Devices intended for performance studies
More information on CE marking procedures can be found in MDR Article 20 and IVDR Article 18. The design of the CE symbol is described in MDR Annex V and IVDR Annex V.