As the coronavirus pandemic continues, the Directorate General of Health (DG Santé) reports that the European Commission (EC) has proposed the Medical Device Regulation (MDR) 2017/745 is delayed by one year.
Update 3rd April 2020: this proposal has been accepted, MDR will be implemented on 26th May 2021.
The extension would take the full implementation date to May 2021. DG Santé said in a letter to the Medical Devices Coordination Group (MDCG):
“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 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.”
MAP will monitor news on the MDR and report the adoption or otherwise of the extension proposal by the Parliament and Council. MedTech companies should refamiliarise themselves with the relevant Medical Device Directives (MDDs) in case these continue to be in force, using MAP Online.
Read the full letter from DG Santé here.