Making The Leap From EU MDD To MDR Clinical Evidence (Part 3): Critical Questions Answered

Do you know how to avoid the pitfalls when it comes to clinical evidence under the MDR? Or whether evidence gathered outside the US counts? Amie Smirthwaite of Maetrics answers these and other pivotal questions in this third and final part of an interview series with Medtech Insight.

All manufacturers wanting to be compliant with the new EU Medical Device Regulation, when it fully applies from 26 May 2021, must review their clinical evidence in the light of the new rules. Picking a way through the new MDR requirements it not always easy.

Here, Maetrics’ Amie Smirthwaite explains the potential compliance pitfalls, when a claim of equivalency can be used and how well...