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...
The last steps are taking place leading to the launch of the EU’s medical device database, EUDAMED.
A recent approval from the US FDA allowing Boston Scientific to broaden its labeling for its pulse field ablation system means more patients with one type of AFib will have access to a promising new treatment.
A revised annex to the original decision also outlines expert remuneration limits and introduces further changes.
