A new 57-page guidance document has been published on the classification of medical devices in the context of the EU Medical Device Regulation. It is intended to help manufacturers and notified bodies chose the correct classification – class I (lowest risk), class IIa, IIb or class III (highest-risk) for each device and understand the rules that apply to them.
The text, MDCG 2021-24, has been endorsed by the Medical Device Coordination Group, the body that supports the European Commission with implementing the new regulation