July 7, 2021

EU MDR Applicability for Changes to Pre-26 May 2021 Devices

Remember (see my post from yesterday) that EU MDR requirements (like EU MDR vigilance procedures, EU MDR corrective action reporting, etc.) generally doesn’t apply for changes involving device units that were legally placed on the market and put into service in the Union prior to 26 May 2021 unless a significant change is made that renders the devices to be “new” devices.  In other words for example, if the change to such pre-26 May 2021 devices are part of a FSCA, then the FSCA requirements of the MDD apply, not the EU MDR.

Particular EU MDR requirements will only become applicable regarding changes to devices placed on the market, made available on the market, or put into service in the Union from 26 May 2021 [notwithstanding the provision of Article 120(5) of course] or regarding significant changes to pre-26 May 2021 units.

Therefore, be careful not to unnecessarily/improperly apply EU MDR requirements to devices legally placed on the market or put into service before 26 May 2021 [except regarding Article 120(5)].