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 IR 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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