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Guidance For Notified Bodies On How To Review High-Risk IVDs Pending EU Ref Lab Appointments

 
• By Amanda Maxwell

The IVD Regulation has tightened the stringency of third-party review of IVDs. But a vital structure is still missing. This is the latest advice for notified bodies on what to do for now.

Scientists

EU notified body association TEAM-NB has published a position paper aimed at notified bodies on the critical matter of how to review the highest risk, class D, IVDs in the absence of the EU Reference Laboratories (EURLs).

It was drawn up in combination with NBCG-Med, a group of notified bodies designated under the IVDR and Medical Device Regulation (MDR) whose remit includes drafting technical recommendations, and reaching

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