Mar 26, 2020

The European Commission has issued a statement that they are working on a proposal to delay the date of application of the Medical Devices Regulation (MDR) by one year. This will go to the European Parliament at the beginning of April, so it may be adopted by the end of that month.

As a reason for this delay the European Commission said it wanted to relieve pressure from ”competent authorities, notified bodies, manufacturers and other actors” to focus on the current COVID-19 crisis, rather than the last-minute preparations for the MDR. It is not clear what exactly is meant by the phrase, “to postpone MDR application date for one year.” This could mean that all timelines related to the date of application move by one year, but it could also mean that only the date of application moves, but the other timelines remain as they are.

Is one year enough time?

It is questionable if one year’s delay would be enough. Medical scientists currently say that it may take a full year before we have a working vaccine for COVID-19; as already suggested by the European Commission themselves, the current crisis deserves our full attention for the months to come.

There is no word yet on the In-vitro Diagnostic Medical Devices Regulation (IVDR), or the impact of this potential delay on congested European Notified Body audit activities.

Only once the new proposal has been published will it become clear how this delay will be set up, and only then industry can prepare. But even then, nothing will change until this proposal has been accepted by the European Parliament and European Council. This may take until the end of April. For now Emergo urges all involved to keep working as if the date of application of the MDR is still on May 26th, 2020. Until the EU rules have formally changed, this is what we all have to work with.

Additional European MDR information from Emergo by UL:

 

Author

  • Ronald Boumans

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