Today, on 25 March 2020, the Commission announced that “The Commission is working on a proposal to postpone the entry into force of the new Medical Device Regulation for one year. We are working hard to submit this proposal early April and we call on Parliament and on Council to adopt it quickly, as the deadline for entry into force is at the end of May. This will relieve pressure from national authorities and industry and will allow them to focus fully on urgent priorities related to the corona virus crisis.”
A few days ago, and despite the Covid-19 crisis, the European Commission had decided to go ahead with the Medical Device Regulation No 2017/745 (MDR) implementation which was due to apply from 26 May 2020. In that sense, the European Commission issued several documents including five guidance documents, showing its determination to ensure that the new requirements would fully apply on 26 May 2020. Among these documents, the European Commission published one of the most awaited guidelines regarding the interpretation of “significant changes” in order to evaluate whether former devices can remain on the market for up to four additional years (available here).
However, due to increasing industry pressure in light of the worldwide Covid-19 crisis and the efforts undertaken by the different actors (such as notified bodies, device companies, the Commission and the national competent authorities) to address the situation and help eradicate the virus, the European Commission eventually took the decision to propose a postponement of the entry into force of the MDR.
This decision is welcomed by the industry as the medical technology industry specifically called for this postponement a few days ago. The postponement should relieve the pressure from all actors involved and allow them to focus on Covid-19 as the most immediate priority. The European Commission also called upon the different actors to use this additional time in an appropriate manner in order to complete all the remaining work to be performed and ensure a proper implementation of the new rules in due course.