EU medical devices regulation postponed to avoid shortage of supplies during SARS-CoV-2 pandemic

The implementation of the new EU medical device regulation, which was due to come into force in 11 days, has been postponed for a year owing to the SARS-CoV-2 pandemic. (Image: Myriam B/Shutterstock)
TextFranziska Beier, DTI

BRUSSELS, Belgium: The European Commission has welcomed the adoption by the European Parliament and the European Council of the proposal to postpone the date of application of the EU medical device regulation (MDR) by one year. The MDR was due to apply from 26 May.

The SARS-CoV-2 pandemic and the public health crisis resulting from it have been putting member states, together with national authorities, health institutions and economic operators, under severe pressure. The present situation is having a strong impact on the different areas covered by the MDR, and it is therefore highly probable that it would not have been possible for all relevant parties to implement and apply the regulation from its planned date of application.

The adopted amendment takes into consideration that the current situation increases the demand for vitally important medical devices across the EU. It is therefore important to avoid any further difficulties or risks of potential shortages or delays in the availability of such devices.

“We are determined to have our medical industries pouring all their energy into what we need them to be doing: helping fight the pandemic”
Margaritis Schinas, European Commission

The European Commission adopted the proposal at the beginning of April, and this was followed by the support of the European Parliament two weeks later. On 22 April, the European Council voted to adopt the proposal and it entered into force upon publication in the Official Journal of the European Union, thus finalising the process. The adopted amendment therefore postpones the application of the MDR by one year—until 26 May 2021. According to the European Commission, the currently applicable rules will continue to guarantee patient health and safety.

In an official press release by the European Commission, Vice President for Promoting our European Way of Life Margaritis Schinas said: “I welcome the adoption in record time by the European Parliament and the Council of the proposal to postpone by one year the date of application of the medical devices regulation. We are determined to have our medical industries pouring all their energy into what we need them to be doing: helping fight the pandemic. The European Union will do whatever it takes to support our health systems in their hour of need.”

Further medical regulations

In order to ensure an effective regulatory framework for medical devices, the present amendment has also postponed the date of repeal of the directive on active implantable medical devices (Council Directive (EEC) 90/385) and the directive on medical devices directive (Council Directive (EEC) 93/42) by one year. However, the present adoption will not impact the date of application of the in vitro diagnostics medical device regulation (Council Regulation (EU) 2017/746), which becomes applicable from 26 May 2022.

“[This] 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,” commented Stella Kyriakides, commissioner for health and food safety, in the European Commission’s press release.