After the vote of the European Parliament and the European Council, the postponement of the new regulation on Medical Devices MDR (EU) 2017/745 is official until May 26, 2021.
The proposal has been published in the Official Journal of the EU
On April 24, 2020, the proposal, which had been submitted by the European Commission, was published in the Official Journal of the European Union.
Stella Kyriakides, Commissioner for Health and Food Safety, said: “Yesterday’s adoption will allow us all, in this time of crisis, to maintain our focus on the most critical issues and to ensure the continued availability of vitally important medical devices. This is clear proof of our ongoing determination to tackle the pandemic through all possible means, while always maintaining the safety of patients as our utmost objective. I thank the Parliament and Council for the record time approval, cooperation and efficient handling of this urgent proposal.”
The health emergency caused by COVID-19 leads to an increase in the demand for some Medical Devices. For this reason, it’s essential to avoid further difficulties or risks of potential limitations of these devices, or delays in making them available.
The adopted amendment therefore postpones the application of MDR (EU) 2017/745 by one year, until 26 May 2021, to allow authorities and Manufacturers alike to prioritise the fight against the coronavirus pandemic by continuing under current procedures.
The present adoption will not have impact on the date of application of the In Vitro Diagnostics Medical Devices Regulation IVDR (UE) 2017/746 (IVDR), which becomes applicable from 26 May 2022.
Although the MDR can be postponed by one year, the requirements to be applied are a lot. For this reason, Thema experts propose a rapid and effective solution: MDR Emergency Kit, a kind of “S.O.S toolbox” in digital format, to solve a possible situation in the most rapid way.
It is already possible to book the MDR Emergency Kit. Contact us as soon as possible!
Thema Staff: phone. 0542 643496 / sales@thema-med.com
Sources:
https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32020R0561&from=IT
https://ec.europa.eu/commission/presscorner/detail/en/IP_20_718
