In a widely anticipated move, the European Parliament has adopted the European Commission’s proposal to postpone the Medical Devices Regulation’s date of application by one year as healthcare regulators, governments and industry grapple with the COVID-19 emergency.
Following the Parliament’s vote to approve the MDR delay, the proposal requires approval by European Union member states and publication in the Official Journal of the European Union, expected no later than May 26, 2020.
Even before the onset of the coronavirus pandemic, many medical device manufacturers were challenged to fully comply with MDR by the Regulation’s original May 2020 date of application. According to Emergo by UL’s Global Medical Device Industry Outlook for 2020, only 48% of respondents indicated a full understanding of MDR requirements as of February of this year, suggesting substantial work still left to do for many firms to meet an extremely tight compliance deadline. With that deadline now pushed to May 26, 2021, more manufacturers as well as Notified Bodies may have won more time to ensure compliance and designation, respectively, to the Regulation.
Learn more about European MDR compliance issues at Emergo by UL:
- EU MDR compliance preparation and resource center
- COVID-19 regulatory resource center
- Whitepaper: Understanding Europe’s new MDR