On January 23, 2024, the European Commission proposed to extend the transition period provided for in Regulation (EU) 2017/746 for in vitro diagnostic Medical Devices (IVDs), aligning itself with the extension of March 20, 2023 for Medical Devices.
Currently,Class A, B and C IVD devices are expected to be compliant with IVDR (EU) 2017/746 by May 26, 2027, and Class D IVD devices by May 26, 2025.
If the European Commission’s proposal is accepted, Article 110 of the IVDR Regulation (EU) 2017/746 will be amended and more time will be given to IVD manufacturers to prepare the technical documentation and the application for product certification.
Here are the new transitional arrangements proposed:
- for high-risk IVD devices, i.e. class D, the transitional period would be extended until December 31, 2027;
- for medium risk IVD devices, i.e. class C, the transitional period would be extended until December 31, 2028;
- for low-risk IVD devices, i.e. class A and B, the transitional period would be extended until December 31, 2029.
However, in order to benefit from the extension, the manufacturer shall fulfil certain conditions, similar to those set out in Regulation 2023/607. First of all, the manufacturer must have implemented a quality management system that complies with the IVDR Regulation, apply for the transition to IVDR and sign a written agreement with a Notified Body, in compliance with the following deadlines:
- for class D IVD devices: by September 26, 2025;
- for class C IVD devices: by September 26, 2026;
- for class A and B IVD devices: by September 26, 2027.
The proposal to postpone the deadlines comes with the overall objective of ensuring patients’ continued access to a wide range of devices, while ensuring the transition to the new regulatory framework and allowing devices that have been placed on the market, and are still available, to remain on the market.
>>> Through the services of strategic-regulatory consulting, support to EC certification and if necessary, European Authorised Representative, Thema can help you implement the requirements of the IVDR (EU) 2017/746.
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