Guidance on how to classify medical devices

A guidance document on classification of medical devices under the EU Medical Device Regulation (MDR) has just been endorsed by the Medical Device Coordination Group.

It is a very useful document to manufacturers when classifying their devices in accordance with the classification rules of Annex VIII of the MDR.

The purpose is to provide an overview of the impact on the classification of medical devices in relation to different aspects of device compliance. The guidance includes practical examples and clarifications in terms of classification.

For more information about medical device regulation, please contact principal toxicologist:

Brian Svend Nielsen
Tel +45 4516 9140