The “period of grace” is the time interval, which coincides with the due date, during which a CE certificate issued pursuant to Directive (MDD) 93/42/EEC can remain effective even after 26 May 2021, but not later than 26 May 2024.

One of the conditions for a “period of grace” CE certificate to remain valid until its natural due date is the demonstration of compliance, starting May 26, 2020, with the requirements of the MDR on post-market surveillance, market surveillance, vigilance and obligations of registration of the Manufacturer and economic operators.

It is important to point out that the MDR certificate is a new certification, not an amendment of the MDD. For this reason, the “period of grace” does not also apply to class I devices or those that pass from self-certification to the control of a Notified Body (including the new I_R class that will include reusable surgical instruments). The demonstration of compliance with the MDR for these devices must be total and complete starting May 26, 2021.

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