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Repeat Solutions Circle
Repeat Solutions Circle
Evaluation ViewAttendees 47

Devices (includes Medical Devices & In Vitro Diagnostics)

EU Notified Body Forum: Tips and Tricks for Effective MDR/IVDR Implementation

Thursday, October 9, 2025
9:15 AM - 10:30 AM EST
Location/Room: 304
Recently, there has been a lot of attention in the EU medtech sector for how the legal framework should evolve, which direction this evolvement should take and what changes are needed with priority. EU Commission and authorities are diligently working on this, while all stakeholders add to the debate by expressing their opinions. This adds to uncertainty in the sector and could ‘distract’ manufacturers, notified bodies and other involved parties from their primary job: effectively bring devices to market under the current legal framework, for the benefit of EU patients.
In this session, representatives from authorities and several EU notified bodies will share their experiences, tips and tricks on how this can be done effectively under the current legal framework. They will also discuss how the extended timelines for transition of legacy devices/IVDs (as per Regulations EU 2023/607 and EU 2024/1860 respectively) can be utilized in the most efficient way.
The format of the session will be a moderated panel debate, preceded by short presentations from panellists. There will be also be opportunity for the audience to ask questions to the panellist directly.

Learning Objectives:

  • Upon completion, participants will be able to understand how effective MDR/IVDR implementation can be achieved
  • Upon completion, participants will be able to explain to their colleagues and hierarchy the benefits and risks of progressing with MDR/IVDR implementation
  • Upon completion, participants will be able to explain to their colleagues and hierarchy how the developments in in EU could have impact on their business strategy