MDR and IVDR Implementation: Update from the European Commission
Regulatory Updates | In-Vitro Diagnostic Devices, Medical Devices
EMERGO SUMMARY OF KEY POINTS:
- 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.
The development of Eudamed is on schedule as well. The implementation plan was published in May 2018, within developers’ planned timeframe, and the functional specifications are now in the draft stage and being reviewed by the EC’s Medical Device Coordination Group (MDCG) for adoption.
Brexit’s impact on Notified Bodies
Brexit has its own dynamics and there too is an issue with Notified Bodies. UK-based Notified Bodies have each taken measures to transfer CE Mark certification operations to European Member States and obtain accreditation to current European Directives for these offices. However, it is not yet fully clear whether these developments mean that all current CE Mark certificates can be easily transferred from UK to European jurisdictions
The European Commission is monitoring the transition and is confident so far all measures appear to be going according to plan: “all is on track.”
Related European MDR and IVDR resources from Emergo by UL:
- European CE Marking strategy for medical devices
- European CE Marking support for IVD devices
- European Authorized Representative in-country representation
- On-site Medical Devices Regulation (MDR) training
- EU MDR 2017/745 gap assessment and transition strategy consulting
- Whitepaper: Understanding Europe’s new MDR 2017/745
- Whitepaper: Understanding Europe’s new IVDR 2017/746