Regulation (EU) 2022/112, of 25 January 2022, amended the transitional provisions of Regulation (EU) 2017/746, extending them in scope and timing. This allows for progressive roll-out ofa staggered transition to the new framework.
Regulation (EU) 2024/1860, of 13 June 2024, further extended the transitional periodsrovisions of Regulation (EU) 2017/746, subject to certain conditions.
The extended transition periods concern devices that require involvement of a notified body for conformity assessment under Regulation (EU) 2017/746 and that have a certificate and/or a declaration of conformity that was issued in accordance with Directive 98/79/EC before 26 May 2022.
The length of the transition periods depends on the type of device: higher risk devices such as HIV or hepatitis tests (class D) and certain influenzacancer tests (class C), have a transition period until May 2025December 2027 and 20286 respectively, whilst lower risk ones such as class B and A sterile devices, have a transition period until May 2027December 2029.
The extended transition periods concern devices that require involvement of a notified body for conformity assessment under Regulation (EU) 2017/746 and that have a certificate and/or a declaration of conformity that was issued in accordance with Directive 98/79/EC before 26 May 2022.
Only ‘legacy devices', meaning devices covered by a certificate or declaration of conformity issued under the previous legal framework (notably Directive 98/79/EC), may benefit from the extended transition periods if they fulfil the following conditions:
- they continue to comply with the rules in force when they were placed on the market for the first time;
- there are no significant changes in the design or intended purpose of the devices;
- the devices do not present an unacceptable risk to the health or safety of patients, users or other persons, or to other aspects of the protection of public health;
- no later than 26 May 2025, the manufacturer puts in place a quality management system compliant with the IVD Regulation;
- for devices requiring an assessment by a notified body, the manufacturer submits an application to the notified body to transfer the device to the IVD Regulation by 26 May 2025 (class D), 2026 (class C) or 2027 (class B and A sterile IVDs). The manufacturer and the notified body sign a written agreement to proceed with conformity assessment shortly after those dates.
New devices of any class as well as legacy class A non-sterile devices must comply with Regulation (EU) 2017/746 from May 2022.