Update: The European Commissioner for Health and Food Safety Stella Kyriakides announced that the commission will propose delaying MDR by one year, due to the resources needed to combat COVID-19. A European Commission spokesperson noted a proposal is expected to be submitted in early April but did not provide further details on the proposal or its approval timeline.
MedTech Europe, the European trade association for the medical device industry, this week called on the European Institutions to pause the Medical Device Regulation (MDR). The association noted that medical device companies’ response to the COVID-19 pandemic disrupts their ability to implement MDR by its transition timeline date of May 26.
“Currently and for the next few months, helping healthcare systems to overcome this outbreak is and will be in everyone’s top priority and focus. Manufacturers are striving to keep needed medical technologies available to healthcare systems while managing the effects of the pandemic on their organisations,” MedTech Europe said in a statement.
MedTech Europe recommended that MDR implementation could resume six months after the COVID-19 crisis has passed, noting that the clock could start again when the World Health Organization or another relevant authority declares the pandemic to be over.
The call for action is in line with those of regulatory and quality professionals who have become increasingly vocal about postponement due to the unknowns still surrounding MDR, the lack of capacity by the small number of notified bodies (12) and now companies’ pressing need to respond to COVID-19.
As recently as March 13, the European Commission’s Medical Device Coordination Group (MDCG) published a Joint Implementation/preparedness plan in which it outlined priorities and noted the significant challenge that manufacturers, notified bodies and authorized representatives face with the short transition period. Mention of COVID-19, which was already spreading throughout Europe at the time, was absent from the report.
MDCG’s paper aimed to agree on where to focus resources in the last two months of the transition. The placement of safe devices on the market was among the priorities.
The group noted, “One concern related to the implementation of the MDR is the potential risk of shortages and disruption of supply of critical medical devices due to the lack of capacity for certification by notified bodies or the risk of reduced product portfolios. It is difficult to quantify the size of this challenge as no specific data has been presented by the industry.”
MDCG said that it believes its December 2019 action to allow reusable Class I devices to follow the Medical Device Directive until 2024 “significantly alleviated pressure on notified bodies” and ensured the continued availability of specific devices (e.g., reusable surgical instruments).
Among MDCG’s priority actions were endorsing certain guidance like the Class I device guidance, endorsing guidance considering “significant changes” that it released last year, and requesting regular reporting from industry and notified bodies to detect possible delays that could lead to medical device shortages.
The Joint Implementation/preparedness plan does not provide new insight into the regulation or its implementation. It simply shares what is being prioritized by MDCG and reconfirms that implementation is not on track as originally planned.
With the current circumstances surrounding COVID-19 and the EU’s own failure to hit key steps during MDR implementation, we expect to hear more pushback on the May 2020 deadline. The question that remains is: Will the EU Commission realize the reality of the day and postpone the deadline?