European Commission has adopted a proposal to postpone EU MDR application by one year The Medical Devices Regulation (MDR) allow Member States, health institutions and economic operators to prioritize the fight against the coronavirus pandemic.
Vice-President for Promoting our European Way of Life, Margaritis Schinas, said:
“Shortages or delays in getting key medical devices certified and on the market are not an option right now. The Commission is therefore taking a pragmatic approach and delaying the entry into application of new EU rules on medical devices, so we can have our medical industries pouring all their energy into what we need them to be doing: helping fight the pandemic. This shows once again that the European Union (EU) is leaving no stone unturned in our support to national public health systems in their hour of need.”
Today’s proposal therefore postpones, for exceptional reasons in the current context, the application of the Regulation (EU MDR) by one year – until 26 May 2021.
The implementation for MDR will take place exactly after one year of the initially scheduled date. The MDR came into force in 2017.
To safeguard an effective regulatory framework for medical devices, it is also necessary to postpone the date of repeal of the Directive on active implantable medical devices and the Directive on medical devices by one year.
The proposal also ensures that Member States and the Commission can address potential shortages of vitally important medical devices in the EU in a more effective manner through EU wide derogations.
EU MDR ensures patients safety and provides clarity on medical device across EU. EU MDR focuses on improving safety and traceability of medical device.
The coronavirus pandemic and the associated public health crisis presents an unprecedented challenge to Member States and is a high burden for national authorities, health institutions and economic operators. The coronavirus crisis has created extraordinary circumstances that require substantial additional resources and an increased availability of vitally important medical devices. None of this could reasonably have been anticipated at the time of adoption of the Medical Devices Regulation (MDR).
Those extraordinary circumstances have a significant impact on various areas covered by the Medical Devices Regulation (MDR). It is therefore very likely that Member States, health institutions, economic operators and other relevant parties would not have been in a position to ensure proper implementation and application of EU MDR. The application for EU MDR was due on 26 May 2020. Hence EU Medical device regulation (EU MDR) is postponed.
This proposal will not affect the date of application of the In Vitro Diagnostics Medical Devices Regulation, which becomes applicable from 26 May 2022.
Manufacturers now have extra time to prepare for stricter requirements of MDR.
Amended transition timelines of Regulations (EU) 2017/745 and (EU) 2017/746Read More
European Commission to consider extensions to MDR and IVDR deadlines?Read More
Quantification of Benefit – Risk AnalysisRead More