Essentials of European Medical Device Regulatory Affairs

The Transition Period and “The Grace Period”

Article 120 MDR

Certificates issued under the directives: Certificates issued prior to 25 May 2017 remain valid for the period indicated on the certificate Certificates issued during the transition period remain valid for the period indicated (maximum 5 years), but become void on 27 May 2024 Example:

• Certificate issued May 2019 – expires May 2024 • Certificate issued Jan 2020 – void 27 May 2024

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Transitional provisions “The Grace Period”

Devices placed on the market under the Directives :

MDs and AIMDs legally placed on the market prior to 26 May 2020 or during the transition period via a valid certificate may be made available up to 27 May 2025 Other Key points: • MDR requirements for PMS, vigilance and registration apply from the end of the transition period – 26 May 2020 • Must remain in compliance with the MDD/AIMD • No significant changes in design and intended purpose • Originally No “grace period” for Class I devices which do not require a certificate i.e. they needed to comply with the MDR from 26 May 2020 • CORRIGENDUM Published 27 th November 2019 has allowed an increase in the transition period for Class I devices requiring NB involvement or Class I devices that are up-classified in the MDR

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