COVID-19: European Commission proposes to postpone the MDR

To ensure that the medtech industry and all stakeholders focus their efforts on the fight against the Covid-19 outbreak and the associated public health crisis, the European Commission has proposed to defer the application of certain provisions of the Medical Devices Regulation (EU) 2017/745 (MDR).

In a proposal for a Regulation dated 3 April 2020 (COM/2020/144 final) (the “proposed Regulation”), the Commission stressed that:

• Medical devices, such as medical gloves, surgical masks, equipment for intensive care and other medical equipment, play a crucial role in the context of the Covid-19 outbreak; they ensure the health and safety of EU citizens and enable Member States to give patients in urgent need of necessary medical treatment.

• The Covid-19 crisis has created extraordinary circumstances that demand substantial additional resources, as well as an increased availability of vitally important medical devices, that could not reasonably have been anticipated at the time of adoption of the MDR.

• Given the unprecedented magnitude of the current challenges, and taking into account the complexity of the MDR, it is very likely that Member States, health institutions, economic operators and other relevant parties will not be in a position to ensure the proper implementation and application of the MDR from 26 May 2020.

• In light of the overriding need to immediately address the public health crisis associated with the Covid-19 outbreak, the proposed Regulation should enter into force as a matter of urgency.

For further details, take a look our Reading Grid outlining the main changes brought by the proposed Regulation.