IVDR Transition Extension (2024)

IVDR applied from 26 May 2022 and introduced risk-based classification (A–D) for IVDs, replacing the IVDD's largely self-certified regime. The proportion of IVDs requiring notified-body conformity assessment jumped from ~8% under IVDD to ~80% under IVDR. Notified-body designation was slow, throughput per body was limited, and by 2023 the Commission's data showed that without an extension a large share of the EU IVD market — including critical-care assays, blood-screening reagents and companion diagnostics — would lose CE marking on 26 May 2025.

Regulation (EU) 2024/1860 resolved this with a class-tiered extension and conditional access to the legacy IVDD certificates beyond their original expiry. The extension is not blanket: manufacturers must take specific procedural steps by milestone dates or lose the extension.

A device benefits from the extended date only if all of the following are true:

1. The device continues to comply with the IVDD (or the certificate it held under IVDD).
2. There is no significant change in design or intended purpose.
3. The device does not present an unacceptable risk to health or safety.
4. The manufacturer has implemented an IVDR-compliant quality management system by 26 May 2025.
5. A formal application for IVDR conformity assessment has been lodged with a notified body by the class-specific milestone date (see below), and a written agreement with the NB has been signed by a later milestone date.

Regulation (EU) 2024/1860 also removed the sell-off date for IVDs already lawfully placed on the market under IVDD (previously 26 May 2025 / 2026 for stock in the supply chain). Devices already in the supply chain may continue to be made available without an additional cut-off, removing the destruction-of-stock cliff that the original IVDR design created.

The extension came with two new obligations applied to all IVDs (and medical devices) under transition. Manufacturers must:

• Give six months' advance written notice to competent authorities, notified bodies, importers and distributors before any interruption or discontinuation of supply that may cause damage to patients or public health (MDR Art. 10a / IVDR Art. 10a, applied from 10 January 2025).
• Inform the competent authority and the relevant NB if expected demand cannot be met, so that mitigating action can be coordinated.

• Devices first placed on the market after 26 May 2022 with no prior IVDD certificate still require IVDR conformity assessment from day one. The extension applies only to legacy devices in transition.
• Class A non-sterile IVDs are self-certified under IVDR and are unaffected by the extension.
• Significant change in design or intended purpose ends the legacy regime immediately for that device.
• Vigilance, post-market surveillance, post-market performance follow-up (PMPF), EUDAMED registration (once the relevant module is mandatory) and SRN obligations apply to legacy-regime devices during the extension.

1. Map every IVD in the portfolio to the new class-tiered sunset date and confirm whether it qualifies for the extension (no significant change, IVDD compliance, no unacceptable risk).
2. Confirm the IVDR-compliant QMS is in place — this is a hard precondition and the 26 May 2025 deadline has passed.
3. For class D devices, application should already have been lodged with a notified body by 26 May 2025 and the written agreement signed by 26 September 2025.
4. For class C devices, lodge the application by 26 May 2026 — do not assume the NB has capacity to absorb a Q1 2026 surge.
5. For class B / sterile A devices, the lodgement deadline is 26 May 2027 but NB capacity will likely be the binding constraint long before then. Engage early.
6. Implement the supply-interruption notification process for all relevant devices — this applies regardless of class.
7. Plan EUDAMED UDI/Device registration in parallel; the EUDAMED mandatory date sits inside the IVDR transition window.