Published on:
09. July 2024
Extension of the Transitional Period for the IVDR in Accordance with Regulation (EU) 2024/1860
The adaptation of the transitional periods for the IVDR, published by the EU Commission in the form of Regulation (EU) 2024/1860, came into force on 9. July 2024 and is intended to give manufacturers and notified bodies more time to implement the requirements of the IVDR. The extended transitional periods apply exclusively to legacy devices with an existing conformity certificate or declaration of conformity and are again staggered according to the risk class of the legacy device:
• Risk class D and devices with a valid certificate under Directive 98/79/EC until 31 December 2027
• Risk class C: until 31 December 2028
• Risk class B and sterile devices of risk class A: until 31 Dezember 2029
The extension is subject to the following conditions:
1. These devices continue to comply with Directive 98/79/EC;
2. No significant changes have been made to the devices (according to MDCG 2022-06);
3. The devices do not pose an unacceptable risk to the health or safety of patients, users, or other persons, or to other aspects of health protection;
4. The manufacturer has established a quality management system according to Article 10(8) of the IVDR by 26 May 2025;
5. The manufacturer has submitted a formal application for conformity assessment to a notified body and has completed it by the following deadlines:
I. 26 May 2025 for risk class D devices
II. 26 May 2026 for risk class C devices
III. 26 May 2027 for risk class B devices
IV. fore the expiry of the certificate under Directive 98/79/EC for the relevant devices
Devices covered by a certificate according to Directive 98/79/EC will continue to be monitored by the notified body during this period. Regardless of these extensions, the requirements of the IVDR for post-market surveillance, market surveillance, vigilance, and the registration of devices and economic operators still apply to legacy devices.
The EU Commission has published a Q&A on practical aspects in parallel.