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EU Notified Bodies Warn Of Major Obstacles To MDR/IVDR Implementation

 
• By Amanda Maxwell

TEAM-NB, the EU notified body association, warns of disruption in device supply if critical action is not taken to ease the path to implementation. It says the many new medtech regulatory shifts, guidance documents and structures adopted in 2021 must be augmented.

Business uncertainty and risk showing a winding road high above the clouds showing the concept of danger and challenges faced in business and the corporate world of finance and financial services.
• Source: Shutterstock/Lightspring

TEAM-NB, the EU association of notified bodies, has issued a position paper on the implementation of the Medical Device and IVD Regulations calling, among other things, for remote initial and surveillance audits to be allowed ̶ when justified by a documented and justified risk-based approach.

The document also requests that notified bodies be allowed to develop best practice themselves, where important documents, such as guidances, have still to be made available. Additionally, it proposes solutions...

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