MDCG Working Groups: Tasks, Membership, Meetings

The Terms of reference of the following MDCG Working Groups were recently published:

  • MDCG Working Group 1: Notified Bodies Oversight (NBO)

  • MDCG Working Group 2: Standards

  • MDCG Working Group 3: Clinical Investigation and Evaluation (CIE)

  • MDCG Working Group 4: Post-Market Surveillance and Vigilance (PMSV)

  • MDCG Working Group 5: Market Surveillance

  • MDCG Working Group 6: Borderline and Classification (B&C)

  • MDCG Working Group 7: New Technologies

  • MDCG Working Group 9: Unique Device Identification (UDI)

  • MDCG Working Group 10: International Matters

  • MDCG Working Group 11: In vitro diagnostic medical devices (IVD)

The Terms of reference define the tasks and roles of each Working Group; the members and chairs; and the structure of meetings.

Apart from the MDCG Working Group 2 on Standards that shall meet annually, all the other Working Groups shall meet at least twice a year.

The Groups are composed of appointed experts coming from EU Member States, as well as third countries participating in the MDCG (Norway, Iceland, Switzerland, Liechtenstein, Turkey).

Other stakeholders can participate – in open sessions – in their role of observers or following an ad hoc invitation. However, Working Group 1 and 5 (Market Surveillance, Notified Bodies Oversight) do not envisage this possibility in their Terms of reference.

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