Coronavirus Impact on EU MDR

Stefanie Wichansky

Stefanie Wichansky About The Author

Mar 28, 2020 2:07:33 PM

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Medical device companies have been scrambling over the past few years to ensure compliance with EU MDR by the mandatory deadline of May 26, 2020. Now it appears that these companies may get a temporary reprieve, as the European Commission (“EC”) has announced that it is working on a proposal for a 1-year postponement of the deadline. The EC is citing the coronavirus outbreak as being the major factor behind the postponement, as it recognizes the need for companies to prioritize this pandemic over final preparations for EU MDR compliance.

With 123 articles and 17 annexes, the EU MDR is lengthy and complex and represents a major overhaul in requirements for the medical device industry. It’s been well documented that manufacturers have been investing substantial time and money to ready their organizations for this new regulation, so as to avoid having their products removed from the market. Not only have many manufacturers been struggling to address the EU MDR in a timely manner, but Notified Bodies are being bombarded as well with the increased demand, resulting in substantial backlogs with scheduling audits. Consequently, this potential delay will be welcomed news for many in the industry.

It is expected that the European Parliament will consider the proposal in early April 2020, with a potential adoption date at the end of April. There still exists some uncertainty at this point as to the full impact of this postponement, particularly whether it will affect other related timelines as well, including timelines for the In-vitro Diagnostics Medical Devices Regulation (IVDR). If and when the proposal gets enacted, these details will be clarified, and the medical device industry can react accordingly.