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Invitation Only
Separate Ticket or Advanced Registration Required
Separate Ticket or Advanced Registration Required
Repeat Solutions Circle
Repeat Solutions Circle
Evaluation ViewAttendees 62

Devices (includes Medical Devices & In Vitro Diagnostics)

EU MDR Kick-Off: “The Latest and Greatest News from Europe

Wednesday, October 8, 2025
9:15 AM - 10:30 AM EST
Location/Room: 304
EU co-legislators’ attention for MDR/IVDR has been unprecedentedly high in 2024. This will have repercussions in 2025 and far beyond. Despite some ‘bright spots’ of successful implementation, the overall picture of MDR implementation continues to be cumbersome. In 2nd half of 2024, both EU Parliament and EU Council expressed their concerns and urged the EU Commission to come with legal proposals for improvement as soon as possible. The EU Commission had already initiated its targeted evaluation of the functioning of the MDR in 2024. They have announced several measures, including 5 implementing and delegated legal acts, for 2025 as ‘quick fix’, while continuing to work on more structural legal changes.

In this panel, representatives of EU Commission, authorities, notified bodies and industry will jointly ‘take the temperature’ of the MDR implementation, including their experience with the postponement of the MDR transition deadlines by Regulation 2023/607. They will describe the steps they are currently taking to give MDR implementation a ‘push’ and how these current initiatives could feed into a bright future for the EU medical device sector and it regulatory system.

The format of the session will be a moderated panel debate, preceded by short presentations from the panellists.

Learning Objectives:

  • Upon completion, participants will be able to understand the latest developments around EU MDR implementation.
  • Upon completion, participants will be able to understand the latest developments around the next steps in the legislative process to review and change EU MDR.
  • Upon completion, participants will be able to include the developments in Europe into the regulatory strategy of their company