Coronavirus delays medical device rules

On 26 May 2020, the Medical Devices Regulation (MDR) was due to come into force. However, in an unprecedented move, the European Commission voted to postpone the regulations by one year to allow Member States, health institutions and economic operators to prioritise the fight against the coronavirus pandemic. 

The vote to delay the MDR was approved by an overwhelming margin on 17 April 2020 and the amendment was published in the Official Journal of the European Union on 23 April 2020. The decision to postpone the regulations took into account the unprecedented challenges of the coronavirus pandemic and the need for an increased availability of vitally important medical devices across the EU while continuing to ensure patient health and safety until the new legislation becomes applicable. 

Speaking on behalf of the European Commission, Margaritis Schinas said: “Shortages or delays in getting key medical devices certified and on the market are not an option right now. The Commission is therefore taking a pragmatic approach and delaying the entry into application of new EU rules on medical devices, so we can have our medical industries pouring all their energy into what we need them to be doing: helping fight the pandemic. This shows once again that the European Union is leaving no stone unturned in our support to national public health systems in their hour of need.”