03.04.2020

EU Commission postpones validity of the new medical devices regulation by one year

Background

The EU Commission today decided to postpone the start of the new medical devices regulation by one year to May 26, 2021. At the same time, the date of repeal of the Directive on Medical Devices ( 93/42/EEC) and the Directive on Active Implantable Devices ( 90/385/EEC) will be postponed by one year in order to maintain a safe legal framework for medical devices. With this decision, the Commission takes into account the exceptional situation in the COVID 19 crisis.

The EU Commission's decision needs the support of the European Parliament and the Council, which is now to be obtained under the accelerated co-decision procedure.

 

Author
Cornelia Yzer

Cornelia Yzer
Of Counsel
Berlin
cornelia.yzer@luther-lawfirm.com
+49 30 52133 21148