By urgent procedure with 693 votes to 1 and 2 abstentions, last April 17 the European Parliament voted the proposal of the European Commission to postpone the application of MDR (UE) 2017/745 by one year, i.e. May 26, 2021.
Given the health emergency caused by COVID-19, there is a fear that there may be shortages or delays in obtaining the Medical Devices necessary to combat this pandemic.
The European Parliament is therefore supporting the proposal to postpone the application of this Regulation by one year to allow authorities and manufacturers alike to prioritise the fight against the coronavirus pandemic by continuing under current procedures.
The proposal has to be approved by the European Council.
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://www.europarl.europa.eu/doceo/document/TA-9-2020-0053_EN.pdf
