The current COVID-19 pandemic is quickly changing everything all around the world and healthcare systems are experiencing an extreme pressure test. Medical device landscape is one of the most critically affected by this situation as the demand of PPEs, ventilators, masks and other devices is increasing by the day.
Taking into considerations all the above, in the past days several categories of medical device industries asked to the European Commission to postpone the entry in force of the Medical Device Regulation 2017/745.
Considering these requests and the general situation, the European Commission has announced that work on a proposal to postpone the date of application of the MDR for one year is ongoing.
The Commission is working to submit the proposal in April so that the Parliament and the Council can discuss it quickly as the deadline for entry into force is the end of May. According to the Commission this will relieve pressure from national authorities, notified bodies, manufacturers and other actors and will allow them to fully focus on urgent priorities related to the coronavirus crisis.
However, there is still much uncertainty about how the MDR will be eventually postponed. It has not been clarified whether the entire regulation or only its most critical aspects will be delayed (e.g. CE markings) and it is not clear which indications will be given to notified bodies regarding the management of CE mark and the possibility of accepting again CE mark applications according to the current directive 93/42.
To date, only this announcement from the European Commission has been made; we expect more details in the coming days.
Regulatory Pharma Net is at your disposal to offer support to manage the transition from the current directive to the new regulation.