Medical Device Regulation- moving towards a transition

Medical Device Regulation- moving towards a transition

The Medical Device Coordination Group (MDCG) is a new body created by the Medical Device Regulation (MDR) and gathers experts from EU Member States to assist the European Commission and the Member States in implementing the new regulatory framework for medical products.

The MDCG meets several times per year and its meetings remain closed to the general public. However, the group produces minutes and some of these insights appeared on the European Commission website.

The last meeting of the MDCG was held earlier this year and the below were the most important outcomes on the timeline & state of play of the Medical Device Regulation implementation for medical products:

  • Implementing act related to Annex XVI moved to 2020,
  • Eudamed: there might be a delay for two modules (Clinical Investigation / Performance Study) and Market Surveillance which may not be available at the time of implementation and will be finalised at a later stage. Only the functional specifications with the timing priority “High (1)” will be for first release to go-live in March 2020. The ones with timing priority “Medium (2)” will be in a next release before end of 2020. The “Low (3)” functionalities will follow later,
  • Notified Bodies: 42 applications received in total, 33 for MDR and 9 for In Vitro Diagnostic Regulaiton - National authorities devote 60 days for checking the applications – 11 days needed for the appointment of the joint assessment team to perform the on-site assessment,
  • Unique Device Indentification (UDI): designation of issuing entities,
  • Nomenclature: CND nomenclature, mapped to Global Medical Device Nomenclature (GMDN) nomenclature- allowing all operators registering their device to find CND nomenclature equivalent to a GMDN code,
  • Vigilance: presentation of three documents:
  1. Manufacturer Periodic Summary Report form (MPSRF),
  2. Device Specific Vigilance Guidance on Cardiac Implantable Electronic Device,
  3. Device Specific Vigilance Guidance on breast implants.

The next meeting of the MDCG is already scheduled and we will keep you up to date with the upcoming developments.

Ajda Mihelcic

17 June, 2019


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