Application of the Medical Devices Regulation (MDR) has been deferred by one year, until 26 May 2021, for fear of shortage or delay in getting essential medical devices needed to combat Covid-19.
The proposal to defer the application of the Regulation was adopted by urgent procedure with 693 votes to 1 and 2 abstentions. The Regulation was adopted in 2017 to improve patient safety and transparency on medical devices across the European Union.
A second Regulation (In Vitro Diagnostic Medical Devices Regulation) corresponding date of application remains unaffected (May 2022).
Source: European Parliament
Contact us at info@arqon.com