Making The Leap From EU MDD To MDR Clinical Evidence (Part 1): Practical Advice
Clinical evidence requirements are among the biggest challenges for manufacturers meeting the requirements of the EU’s new Medical Device Regulation. Maetrics’ Amie Smirthwaite explains how manufacturers should transition from the one to the other in part one of a three-part interview series with Medtech Insight.
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Maetrics’ Amie Smirthwaite explains the fundamental differences in clinical evidence expectations under the MDR compared with the MDD in part two of a three-part interview.
The European Commission’s proposal to extend transition timelines for legacy devices in the context of the Medical Device Regulation is already on the move. There are still questions, however, about whether a fast-track adoption is in the best interests of the medtech sector.
A review of expert panel opinions related to high-risk medical devices shows no challenges yet by notified bodies to their findings.