Faced with Covid-19 Pandemic, European Commission Delays MDR

As COVID-19 continues to ravage the globe and redefine priorities for the medical device industry, the European Commission has decided to delay the May 26 implementation of the Medical Devices Regulation (MDR) by one year.

The move follows lobbying by representative bodies in the medical technology industry, and the delay comes as a relief to device manufacturers – questions about readiness have lingered for months and have primarily focused on whether notified bodies would have enough capacity. The one-year postponement also recognizes the burden that medical device manufacturers face in trying to supply healthcare workers with the equipment to fight COVID-19 and maintain business operations while countries are on lockdown.

While the announcement buys manufacturers some much-needed breathing room to get their houses in order in terms of compliance, it’s still advisable not to let the new deadline sneak up on you. For more information on how Argos Multilingual can help you use this additional window of opportunity to get prepared, please visit us at mdreurope.com.

Want to know more?

• Blog: Understanding the Impact of the EU Medical Device Regulation (MDR) on IFUs
• Whitepaper: EU MDR & EU IVDR Checklist