Europe – MDR and IVDR Implementation: Update from the European Commission

  • MDR and IVDR implementations still on track as planned.
  • The first Notified Bodies to be designated may be announced by the end of 2018.
  • Eudamed is advancing as planned.
  • Brexit is a matter of concern, but all UK based Notified Bodies appear to be taking appropriate actions.

The European Commission reports that implementation efforts for the EU Medical Devices Regulation (MDR) 2017/45 and In Vitro Diagnostic Medical Devices Regulation (IVDR) 2017/746 remain on track, as well as related efforts regarding Notified Body designations and Eudamed database development.

In her closing statement on MDR and IVDR implementation, Elżbieta Bieńkowska, Member of the EC, gave answers to concerns raised by the European Parliament about the transition process of the current Directives to the new Regulations). She denies being “optimistic and calm,” but rather “realistic and confident.”

First Notified Body designations to MDR, IVDR by year’s end?

So far, 34 of the current 60 Notified Bodies for medical devices and IVDs have applied for designation under the MDR and/or IVDR. According to Ms. Bieńkowska there have been no delays in the application process. In fact, the process appears to be slightly ahead of schedule: the first Notified Bodies designated under the MDR and/or IVDR can be expected before the end of 2018. However, Emergo has yet to receive confirmation from its Notified Body sources on this issue…