Last April 3, 2020 the European Commission officially proposed to postpone by one year, until May 26, 2021, the application date of the MDR (EU) 2017/745 to allow the Member States and the Health Institutions and the Economic Operators to give priority to the battle against COVID-19 pandemic.

The European Commission considers that the medical emergency caused by COVID-19 pandemic must be faced by making a great amount of Medical Devices available in the European Union, in order to guarantee patients health and safety until the new regulation enters into force.

The Commissioner for Health and Food Safety Stella Kyriakides stated: “Our priority is to support the Member States in dealing with the crisis provoked by COVID-19 and protect the public health in the best possible way, with all the necessary means. Any potential market disruption concerning the availability of essential and safe Medical Devices must and shall be avoided. The current decision is a needed measure in these extraordinary times.”

By the end of April the European Commission proposal will be evaluated and eventually accepted by an accellerated co-decision procedure by the European Parliament and by the European Council, defining the relevant details.

Concerning the IVDR (EU) 2017/746 the application date would remain May 26, 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

Source:

https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=COM:2020:144:FIN&from=EN