News - November 28, 2019

MDR: Second Corrigendum aims at Class 1 Devices

The Council of the European Union has published a second set of corrections as part of a corrigendum for the EU’s Medical Devices Regulation (MDR), this time giving manufacturers of certain Class I devices an additional four years to comply.

With this corrigendum, all Class I devices under the current Directive that would be up-classified under the MDR would be able to make use of the soft-transition and thus have up to 4 additional years, until 26 May 2024, to comply to the new regulations in full. The corrigendum first needs to be adopted by the European Parliament to take effect.

In addition, devices lawfully placed on the market pursuant to the device directives prior to 26 May 2020 may continue to be made available on the market or put into service until 27 May 2025, the regulation says. But the corrigendum corrects this later date to 26 May 2025.

The corrigendum is available here.