Team-NB Position Paper on MDR/IVDR revisions

Team-NB, the European Association of Medical devices Notified Bodies, has published its Position Paper on the European Commission’s proposed revisions to the MDR and the IVDR.

While the Association acknowledges that the proposed revisions provide opportunities to improve predictability, transparency and efficiency in conformity assessment, it has expressed concern regarding some aspects of the proposed revisions.

These include what Team-NB perceives as reductions in scrutiny which would result from the proposed revisions and which the Association believes risks reducing oversight to levels below those under the previous Directives, with potential implications for patient safety, trust and market supervision.

The European Commission’s claim that the proposed revisions could save €2.1 billion was also rejected by Team-NB. In light of total notified body revenue in recent years the Association considers that even drastic cuts in notified body activities could not achieve these savings.