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EU Position Paper Outlines Notified Body View On Hybrid MDR/IVDR Audits

 
• By Eliza Slawther

Hybrid audits of quality management systems (QMS) can satisfy certain requirements of new EU medtech regulations while improving efficiencies, TEAM-NB has said. In a new position paper, the association details how and when hybrid audits are appropriate.

Audit
• Source: Shutterstock

The EU’s medtech notified body association, TEAM-NB, issued on 26 September a position paper on the use of hybrid QMS audits in line with conformity assessment requirements set out in the EU Medical Device and In Vitro Diagnostics Regulations (MDR/IVDR).

While the information set out in the position paper appears to be guidance for notified bodies, TEAM-NB included a disclaimer in the document that it is the organization’s “view/expectation...

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