Module 18 2021

06/02/2021

2025, May 26 Sell-off provision

2022, May 26 Full Applicability

2024, May 26 Grace period List A/List B

2017, May 26 IVDR entry into force

IVD-R

5 years transition period

Devices that are still in the supply chain before May 25, 2022 and have not reached their final user are marketable until May 25, 2025

IVD-D

IVD-D List A and List B devices with valid IVDD certificates can be further manufactured under specific requirements

Transition timelines from the Directive to the new IVD Regulation

The Organisation for Professionals in Regulatory Affairs

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‘Companion diagnostic' means ’ a device which is essential for the safe and effective use of a corresponding medicinal

product to :

- identify , before and/or during treatment

- patients who are most likely to benefit from the corresponding medicinal product; or

- patients likely to be at increased risk for serious adverse reactions as a result of treatment with

the corresponding medicinal product

Class C / Classification Rule 3 (f) = Devices intended to be used as companion diagnostics

IVDR introduces a definition for Companion Diagnostics for the first time in the EU

The Organisation for Professionals in Regulatory Affairs

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