European Commission update on the MDR implementation

Today, at a conference in Brussels, the European Commission shared important points and dates regarding the MDR implementation and preparedness of the regulatory framework, and main actors for May 2020.

Notified Bodies (NBs)

  • As of February 2019, 33 NBs applied under the MDR and 9 NBs under the IVDR; so far, there were 25 Joint Assessments performed and 3 are scheduled;

  • New designations of NBs can soon be expected and significant number of newly designated NBs is estimated by end of 2019;

MDCG Working Groups will be operational from 1st of March 2019 (List of observers should be shortly published); So far, MDCG met eight times, you can here find a schedule of MDCG and its subgroups meetings;

Functional specifications for EUDAMED should be released next week;

Designation of UDI issuing entities is expected by May 2019;

By mid-2019:

  • Guidance on vigilance (April/May)

  • Guidance on software

  • Guidance on classification

  • Guidance on clinical evidence

Under preparation:

  • Guidance for substance-based devices

  • Common Specifications on Annex XVI

  • Common Specifications on reprocessing (as well as Implementing Act)

It was indicated by other speakers that the first NB designated under the IVDR is forecasted for July 2019!

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