EC Propose Postponement of Medical Devices Regulation due to COVID-19
As of 25 March 2020, the European Commission (EC) announced that their services are working on a proposal to postpone the implementation of the Medical Devices Regulation (MDR – 2017/745) by one year (to May 2021). This announcement has been made following increasing pressure from industry in the face of the COVID-19 pandemic.
In a letter to the Medical Devices Coordination Group (MDCG), the EC health and safety medical devices unit stated:
“As such, today (25 March 2020), and with patient health and safety as a guiding principle, the Commission announced that work on a proposal to postpone the date of application of the MDR for one year is ongoing. We are working to submit this proposal early April and we call on Parliament and Council to adopt it quickly as the deadline for entry into force is the end of May. This will relieve pressure from national authorities, notified bodies, manufacturers and other actors and will allow them to focus fully on urgent priorities related to the coronavirus crisis”.
This constitutes a relief for the whole sector, as the COVID-19 outbreak had hampered all players involved in the implementation of the MDR (industry, notified bodies and competent authorities).
In a letter to the EC health and safety medical devices unit, the European Confederation of Pharmaceutical Entrepeneurs (EUCOPE) requested a postponement as many small and medium-sized companies are working tirelessly to product the necessary life-saving technologies to support health workers and hospitals fight this pandemic.
They also raised that the COVID-19 outbreak hampers the implementation process of the MDR:
“The most striking effect derives from travel restrictions: Notified Bodies are not in a position to send their experts for inspection anymore, impacting their auditing and certification capacity and delaying even more the designation procedures.”
A postponement will allow all healthcare actors to retrieve their normal practice and devote resources to implement the regulations in a more reasonable way.
Here at JensonR+, we will be continuing to monitor the situation in 2020 and beyond, so follow us on LinkedIn to receive any updates. If you would like to discuss the potential impact of this change to your business, then please do not hesitate to contact us at email@example.com.