Essentials of European Medical Device Regulatory Affairs

IVDR Timeline

2022 Device No.1 Certified under new IVD Regulation

2017 Device No.1 Certified under  current  IVD  Directive

2020 Device No.1 Re-certified under current IVD Directive or IVDR

2019 Device No.2 Certified under  current IVD  Directive or IVDR

2022 Device No.2 Certified under new IVD Regulation

2016

2017

2018

2019

2021

2023

2025

Early 2017 Regulations formally adopted and enter into force

2019 NBs 1 st wave re-designation, can only issue IVDR certs - NB here

Early 2025 Devices placed on EU market must be certified under new IVDR

Early 2022 IVDR fully applied

Q2 2017 NB to start assessing

against IVDR requirements but no new cert to be issued

Q1 2017 & Q1 2021 4 years of pre-assessment to manage

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Implementation – priorities & challenges

European Commission • Eudamed & UDI system • NBOG codes – enabling act published • Expert panels • Implementing / delegated acts (43 in MDR), common specifications and guidance. National agencies • Defining national policy (where there are Member State derogations) • Re-processing • In-house manufacturing • Re-designating NBs – plan needs to be published and consistent across EU for manufacturers and Notified Bodies.

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