​​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. 

Publisert: 19.04.2022

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