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Evaluation

Medical Devices

MDR Kick-off Panel

Wednesday, May 14, 2025
08:30 - 09:30 CEST
Location: Gold Hall (level 0)
Learning Level: Intermediate
Description: This session focuses on the regulatory actions and activities that the EU is considering to further optimize the regulatory approval processes under the MDR in Europe, by streamlining and optimizing the processes in general, and specifically also towards innovation, breakthrough devices, orphan devices and well-known legacy devices, to support both large industry and SME’s. Perspectives will be shared from the viewpoint of the EU Commission, a key notified body, and an industry perspective. The session is a combination of short presentations and panel discussions that are interactive with the audience

Learning Objectives:

  • Upon completion, participants will be up to date with the latest state of play of the implementation of MDR, from the perspective of EU COM, national competent authorities, notified bodies and manufacturers
  • Upon completion, participants will be aware of the results of the EU Commission´s study on governance and innovation.
  • Upon completion, participants will be able to understand the process steps that have been taken By EU Commission in the targeted evaluation process