Essentials of European Medical Device Regulatory Affairs - June 2020

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 2021 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 2021 • 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 2021 • 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

7

MDR Transition Period

1 year delay on date of application but grace period remains unchanged

TheOrganisation for Professionals in Regulatory Affairs

Scope and definitions

Chapter I

Articles 1-4

• What is and what is not a medical device

• Medical Device definition

• Medicinal Products

• Combination/integral products

• Borderline Products

TheOrganisation for Professionals in Regulatory Affairs

3