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EU Classification ‘Bible’ Published To Support Risk Class Decision-Making

 
• By Amanda Maxwell

The risk class of a medical device depends on its intended purpose and mode of action. But these are not always easy to determine. Now there is EU guidance to support this decision-making.

Risk

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...

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