Regulation (EU) 2024/1860
Regulation (EU) 2024/1860 extended the IVDR transition periods for legacy IVDs that need a Notified Body under the IVDR. Each class has its own final date and its own intermediate milestones.
| IVDR class | Final date | Application to a Notified Body by | Written agreement by |
|---|---|---|---|
| Class D | 31 December 2027 | 26 May 2025 | 26 September 2025 |
| Class C | 31 December 2028 | 26 May 2026 | 26 September 2026 |
| Class B and Class A sterile | 31 December 2029 | 26 May 2027 | 26 September 2027 |
In every case the manufacturer must have had a quality management system in place under the IVDR by 26 May 2025, and the device must continue to comply with the IVD Directive without significant changes in design or intended purpose.
Regulation (EU) 2024/1860 also introduced Article 10a in both the MDR and IVDR: where a manufacturer anticipates an interruption or discontinuation of the supply of certain devices that could result in serious harm or a risk of serious harm to patients or public health, it must inform the competent authority and the economic operators, health institutions and healthcare professionals it supplies directly, at least six months in advance except in exceptional circumstances.
31 December 2027 for Class D, 31 December 2028 for Class C, and 31 December 2029 for Class B and Class A sterile legacy devices, subject to the conditions in Regulation (EU) 2024/1860.
By 26 May 2025, for all classes relying on the extended transition.
A duty to inform the competent authority and directly supplied customers at least six months in advance of an anticipated interruption or discontinuation of supply that could result in serious harm.
IVDR classes A to D.
Evidence planning for IVDs.
Structured request.
Note: This guide provides general information about Regulation (EU) 2017/745 (MDR) and Regulation (EU) 2017/746 (IVDR), not legal advice. Check the consolidated text on EUR-Lex and the relevant MDCG guidance for your device. Last reviewed 30 September 2026.