Notified Bodies And EU Industry Voice Separate, But Aligned Frustrations Over Slow Progress In NB Designations

Notified body and medtech industry trade associations both issued formal statements pointing out that delays in designating notified bodies are the biggest barrier to products being able to comply with the new EU Medical Device Regulation before deadlines. Time is running out.

Notified bodies will not be able to assess and take certification decisions for all applications before May 26, 2020, the full application date for the MDR.

That is the warning from the EU notified body trade association, TEAM-NB, in a white paper titled "One Year...

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