The European Council has voted unanimously to delay the implementation of the Medical Devices Regulation (MDR) by one year and allow for EU-wide exemptions for certain medical devices needed in the response to the COVID-19 pandemic.
The measure was approved in record time, coming less than three weeks after the European Commission initially proposed the delay. The year-long delay will not alter the substance of the MDR. It aims to avoid disruption of the medical device market and prevent any delays in the availability of devices needed to address the COVID-19 outbreak.
Stella Kyriakides, European Commissioner for Health and Food Safety, says:
“[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.”
Medical device industry group MedTech Europe has called for a similar delay for the In Vitro Diagnostic Regulation (IVDR), which is still set to take effect on 26 May 2022, noting that progress on IVDR implementation has halted since the COVID-19 outbreak began.
The amendment, published in the Official Journal of the European Union, can be read here.