Search

Home > Medical Device made Easy Podcast > Simplifying EU Medical Device Regulations: Understanding the 2025 Proposal
Podcast: Medical Device made Easy Podcast
Episode:

Simplifying EU Medical Device Regulations: Understanding the 2025 Proposal
Category: Business
Duration: 00:00:00
Publish Date: 2025-12-24 23:27:39
Description:
miniature episode podcast 368 Simplifying EU Medical Device Regulations: Understanding the 2025 Proposal monir el azzouzi easy medical device

The European medical device sector is a vital pillar of healthcare innovation, employing over 930,000 people and representing a market of approximately €170 billion. However, since the implementation of MDR and IVDR, manufacturers—especially SMEs—have faced increasing regulatory complexity, long certification timelines, and reduced market predictability.

In this podcast episode, we explore the 2025 EU proposal designed to address these challenges by simplifying regulatory processes while preserving patient safety.

The discussion covers:

  • Key shortcomings of the current MDR/IVDR framework
  • The impact on innovation, availability of devices, and SMEs
  • The eight reform pillars, including proportionality, digitalisation, international cooperation, and improved coordination with EMA and Notified Bodies
  • How upcoming EU legislation (AI Act, Cybersecurity Act, Biotech Act) will interact with medical device regulations

This episode provides practical insights for manufacturers, regulatory professionals, and policymakers seeking to anticipate regulatory changes and adapt their strategies accordingly.

</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.