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Evaluation ViewAttendees 53

Devices (includes Medical Devices and In Vitro Diagnostics)

Notified Body Forum: State of Play EU MDR and EU IVDR

Thursday, September 19, 2024
9:15 AM – 10:30 AM PDT
Location/Room: 102
Intermediate Level
Description: In 2022, the increased transparency regarding the status of implementation of both the EU MDR and the EU IVDR led to reasonable measures towards supporting the healthcare system continuity in the EU, including various delays in the timelines. The amended regulation 2023/607 and the commitment of both the EU Commission and Notified Bodies towards leaner implementation of the regulations are deemed to be a big relief to the system.
In this notified body / authority forum, the EU Commission, representatives from EU Member states and notified body representatives will discuss the state of play just before the important deadline of 26 September 2024, when all contracts between manufacturers and notified bodies for devices transferring from Directives to the MDR need to be finalized. The discussion during this forum will focus on the effectiveness of the implemented measures to achieve the planned full transition to the EU MDR by the end of 2028. For EU IVDR, a similar analysis will be discussed, based on the expected legislative measures of early 2024 to achieve full IVDR implementation.

Learning Objectives:

  • State of play just before the important EU MDR transitional deadline of 26 September 2024
  • Input of various stakeholders regarding the effectiveness of the implemented measures to achieve full EU MDR Transition
  • Feedback regarding the expected legislative measures of early 2024 to achieve full EU IVDR implementation