Making The Leap From EU MDD To MDR Clinical Evidence (Part 2): Differences In Expectations
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.
You may also be interested in...
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.
The UK responsible person is the UK equivalent of the Authorized Representative in the EU. MedTech Europe’s Jesús Rueda gives an update on the early experiences of medtech manufacturers seeking to comply with the UK’s new standalone regulations.
The European Commission has reluctantly allowed virtual audits in the context of new MDR and IVDR. The EU notified body association is helping the collective effort to meet its strict requirements.