The COVID-19 outbreak and the associated public health crisis is placing an immense burden for authorities, healthcare providers and manufacturers. In response to these extraordinary circumstances, the European Union has decided to prolong the transition period for the Medical Device Regulation by one year. The Regulation delaying the Date of Application to 26 May 2021 was published today in the Official Journal of the European Union; it can be read here. You can also read the European Commission’s press release here.
COCIR welcomes this decision; it will help our member companies focus their efforts on continuing to supporting patients, healthcare professionals and hospitals in their fight against COVID-19. The European Union institutions have shown decisive and pragmatic leadership in what are unprecedented circumstances. Regulators now need to implement the necessary processes to ensure that devices can continue to be placed on the European market under the existing Medical Device Directives until the new Date of Application.
COCIR will, of course, continue to support an effective implementation of the new Regulation. With our experts, we remain engaged in the various dedicated Working Groups in supporting the development of the required secondary legislation and guidance documents.