Essentials of European Medical Device Regulatory Affairs - October 2019

The Transition Period and “The Grace Period”

Article 120 MDR and Article 110 IVDR Certificates issued under the directives: Certificates issued prior to 25 May 2017 remain valid for the period indicated on the certificate except: • MDD Annex IV certificates void 27 May 2022 • AIMD Annex 4 certificates void 27 May 2022 • IVD Annex VI certificates void 27 May 2024 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, AIMDs and IVDs 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/IVDR requirements for PMS, vigilance and registration apply from the end of the transition period

• Must remain in compliance with the MDD/AIMD or IVD • No significant changes in design and intended purpose

• There is no “grace period” for Class I devices which do not require a certificate i.e. they need to comply with the MDR from 26 May 2020

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