Nancy Morrison, R&Q's Executive Director, Regulatory & Quality Consulting Services, shares her thoughts on the potential impact of the COVID-19 pandemic on the EU MDR timeline:
Team NB, the European Association of Notified Bodies (NB) that are active in the medical device sector, released a short statement on March 12 discussing the anticipated impact of COVID-19 on the Notified Bodies. See their statement here.
Per the statement, the outbreak and associated travel restrictions are affecting the Notified Bodies’ ability to conduct both Medical Device Regulation (MDR) audits and surveillance audits to existing directives. Team NB assures readers that the Notified Bodies are discussing contingency plans with the competent authorities to work through the issues ahead.
R&Q Subject Matter Expert Dr. Ibim Tariah, Vice President of EU MDR and IVDR Consulting Services, says that given the ripple effect COVID-19 has already had on medical device global business capabilities, travel and the workforce, we may see an impact on the MDR timeline and especially the upcoming May 26 date of application. We see that COVID-19 is having a ripple effect through the MDR certification process and may continue to do so for years ahead. At this time, only 10 Notified Bodies (out of 56 MDD designated NBs) have been designated to the MDR to date.
Additionally, COVID-19 is further reducing the European Union competent authorities’ ability to conduct the necessary activities to designate additional Notified Bodies. COVID-19 effects of travel restrictions, reduced workforce, and the lock down in Italy have enormously compounded an already challenging endeavor for the competent authorities to designate more NBs in a timely manner. As a result, a heavy workload concentrated to a small number of NBs leaves many manufacturers with undesignated notified bodies at a loss for a path and the necessary guidance to MDR certification.
Current Notified Bodies certainly have the capability to conduct some audit activities remotely, but there are portions of the conformity assessment process, such as verifying manufacturing processes, that must be done at the physical manufacturing facility. There is a requirement of some amount of on-site work that is required prior to issuing CE certificates and due to social distancing measures being put in place across the globe, it is difficult to know when these necessary audits will resume.
On the other hand, even if the Notified Bodies were able to travel, medical device manufacturers are working through the enormous challenges of a reduced workforce imposed by COVID-19 limitations. Of course we must mention the manufacturers that work with a critical supplier or manufacturing site in China experiencing additional barriers to successful audits – and that’s a topic that requires an entire post of its own!
Despite no official word from the European Commission on an EU MDR date of application extension at this time, we believe that these external influences caused by COVID-19 may result in the reconsideration of the date of application on May 26, 2020. It will take an act of Parliament to change the date of application, advised by the European Commission which could result in another corrigenda being published, such as when Class 1R devices were delayed. In the past, we have seen other EU regulations extended or partially extended at the last minute. In 2016, for example, the EU Commission delayed the date of applicability for the PRIIPs Regulation (financial disclosure) by one year. The statement was issued November 6, 2016 extending the date of applicability until January 1, 2018, which was only seven weeks before the due date.
As with so many important decisions during this challenging and uncertain time, it is difficult to predict what the extension might be, if any. A reasonable request from industry would be an extension to existing certificates in an abbreviated fashion. Currently, however, there are only rumors and no official statements from the Commission committing to such an extension. In fact, they just released new guidance this week – see our blog post here. We believe a change will be difficult and if it happens it will occur in the final hour. R&Q experts are advising manufacturers to keep working on compliance to the target dates even though the virus may be the final straw needed to push the Commission to act.
In the meantime, our remarkable remote support team is available across all R&Q services and we're ready to answer any questions or concerns you have about how to stay on track for the EU MDR timeline. We can help you navigate the difficult road ahead and we have ample virtual content to keep you in the know.
Source: Schlemmer, F. Team-NB. Team-NB stat[e]ment on Covid 19. Published 12 March 2020. Accessed 19 March 2020. https://www.team-nb.org/publication-of-a-statement-on-covid-19/
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