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Evaluation ViewAttendees 9

Medical Devices

MDR 2.0: Kick-off Panel 2026

Wednesday, May 6, 2026
08:30 - 09:30 WEST
Location: Auditorium 1
Learning Level: Expert
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 to make the system more cost-effective in general. Key elements of improvement focus on innovation, breakthrough devices, orphan devices and well-known legacy devices, to support both large industry and SME’s. In addition, the notified body processes may be streamlined further, initiating time-constraint for various conformity assessment steps and introducing clock stops. Perspectives will be shared from the viewpoint of the EU Commission, a representative from a member state, 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 latest upcoming legislative finetuning and improvements.
  • Upon completion, participants will be able to understand the process steps that have been taken by EU Commission in both the short-term enhancements, as well as in the targeted evaluation process.