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Guidance Sets Out How Notified Bodies Must Assess Highest Risk IVDs Under New Regulation

 
• By Amanda Maxwell

The highest risk IVDs, which fall into class D, are subject to additional testing criteria. New guidance explains how the notified body acts − not only as reviewer but also as facilitator so additional safety and performance guarantees can be sought.

Gloved hand performs COVID-19 testing in a laboratory setting.
• Source: Alamy (tilialucida / Alamy Stock Photo/Alamy Stock Photo)

The European Commission’s Medical Device Coordination Group has published an 11-page guidance document on the verification of manufactured class D IVDs by notified bodies, MDCG 2022-3. It has been issued in the context of the new IVD Regulation, which applies on 26 May.

This guidance also describes best practices for notified bodies in performing conformity assessment procedures relating to the verification of manufactured class D IVDs, the highest risk class in the IVDR....

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