Search

Home > Medical Device made Easy Podcast > Clinical Evidence under EU MDR – Why So Many Dossiers Fail (and How to Fix It)
Podcast: Medical Device made Easy Podcast
Episode:

Clinical Evidence under EU MDR – Why So Many Dossiers Fail (and How to Fix It)
Category: Business
Duration: 00:00:00
Publish Date: 2025-10-16 00:42:50
Description:
Miniature episode 358 Clinical Evidence under EU MDR – Why So Many Dossiers Fail (and How to Fix It) monir el azzouzi easy medical device

Since the implementation of EU MDR 2017/745, clinical evidence has become one of the biggest challenges for medical device manufacturers — and a major source of Notified Body nonconformities.

This episode breaks down the root causes behind failed submissions and offers a practical framework to fix them:

  • Understanding the shift from MDD to MDR (Article 61 & Annex XIV)
  • Why weak Clinical Evaluation Plans (CEPs) lead to rejection
  • How to generate and analyze real, device-specific clinical data
  • Integrating Post-Market Clinical Follow-up (PMCF) into your PMS system
  • Maintaining a “living” Clinical Evaluation Report across the device lifecycle

</td> </tr> <tr> <td> Total Play: </td> <td></td> <td> 0 </td> </tr> </table> </form> <audio controls autoplay style= Your browser does not support the audio element.