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Will the EU postpone 2017/745 MDR Implementation - COVID-19 Impact

fialor

Involved In Discussions
#1
Hello All,
Has anyone come across any news of the possible postponing of the MDR coming into force on the 26th of May 2020?
I expect that a lot of NBs will struggle to fulfil and support their customers in MDR CE marking their products.
It was a really tall tree to climb, and the COVID-19 crisis will now compound the issue.
It is going to be an interesting few months.
 

yodon

Staff member
Super Moderator
#2
Seems like they're all boxed in. NBs are no longer doing CE marking based on the MDD. Clearly a number of things (like Eudamed) are already delayed and will likely be delayed longer. Has all the trappings of getting quite messy.
 
#4
The European Commission published a document on March 11 with some related information. I don't have enough posts to be able to add the link, but here is an overview from our AR:

On March 13th, 2020, the European Medical Device Coordinating Group (MDCG) published the Joint Implementation/preparedness plan on the new Medical Devices Regulation (EU) 2017/745 (MDR). This plan has been drawn up by the European Commission together with the Member States, but it calls on all stakeholders involved to further step up their efforts and work together to achieve an operational system by May 2020. This plan aims at setting priorities and providing means to do so.
This plan has been drafted after calls from the European Council on December 9th, 2019, where health ministers requested a readiness check, and as result of the MDCG meeting of December 13th, 2019, where MDCG members wanted to see a list of key priorities that need to be finalized by May 2020. The priorities have been based on the interests of:
  • Public health;
  • Patient safety;
  • Transparency.
Conclusion
The Date of Application of the MDR, Brexit, Swixit and now complications stemming from the COVID-19 pandemic are whipping up what had already been seen as a very complex and ambitious exercise into a perfect storm of complexity. The Joint Implementation/preparedness plan does not provide major new insights to untangle this immense knot. It mainly confirms what has already been communicated by others: the MDR implementation is not running according to plan.
It appears that, unless European citizens are willing to accept unpredictable disruptions in the continuity of their care due to devices not being available, the current timelines for the implementation of the MDR need to move significantly.
 
#7
This release from the European Commission. Only a proposal at this point.
Today (25 March 2020), the Commission announced that work on a proposal to postpone the date of application for the Medical Device Regulation (MDR) for one year is ongoing. The decision was reached with patient health and safety as a guiding principle. The Commission is working to submit this proposal in early April for the Parliament and the Council to adopt it quickly as the date of application is the end of May. This decision will relieve pressure from national authorities, notified bodies, manufacturers and other actors and will allow them to fully focus on urgent priorities related to the coronavirus crisis.
 
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