Article 110 extends the clock, not the duties

Regulation (EU) 2017/746 replaced the old In Vitro Diagnostic Medical Devices Directive on 26 May 2022, and Article 110 is the provision that decided what happened to every IVD already on the market when the switch took effect. This blog has already covered the equivalent provision for medical devices, MDR Article 120, and the two get read as interchangeable because they solve the same-sounding problem on the same-sounding timeline. IVDR's version runs on a different structure, with different per-class deadlines and a different starting condition — and Regulation (EU) 2024/1860, in force since July 2024, rewrote Article 110(3) specifically because the original single 2025 cutoff didn't fit the shape of the IVD market it was written for.

A cliff edge became a staircase

IVDR as adopted set one hard date, 26 May 2025, after which legacy IVDs placed on the market under an IVDD certificate or self-declaration would lose their transitional cover outright. Regulation 2024/1860 replaced that single date with a staggered schedule keyed to device class: Class D legacy devices keep transitional cover through 31 December 2027, Class C through 31 December 2028, and Class B and sterile Class A through 31 December 2029. Non-sterile Class A devices get no extension at all — they were self-certified against IVDR requirements from the regulation's own 2022 application date and never had legacy cover to extend in the first place.

Three conditions keep the extension attached to the device

The extended date isn't a blanket grant. Article 110(3) ties it to conditions a device has to keep meeting: the device continues to comply with the directive it was certified under, and it carries no significant change in design or intended purpose. On top of that, the 2024 amendment layered procedural deadlines of its own — a manufacturer needs an IVDR-compliant quality management system in place by 26 May 2025, regardless of device class, and has to lodge a formal application for conformity assessment with a notified body by a class-specific date: 26 May 2025 for Class D, 26 May 2026 for Class C, and 26 May 2027 for Class B and sterile Class A, followed by a signed written agreement with that notified body within months of the application. A device that drifts past any one of these markers loses the extension for that specific device, independent of what class it holds.

Most of these devices have never met a notified body

MDR's Article 120 extension mostly buys time for devices that already had a notified body relationship under the old directive — the certificate just needs renewing under the new rules. IVDR's population looks different: the IVD Directive let the large majority of in vitro diagnostics reach the market through self-declaration, with no notified body ever reviewing the file. Article 110's staggered deadlines are mostly extending the runway for those self-declared devices to find a notified body, get evaluated, and get certified for the first time — a heavier lift than renewing an existing relationship, and the reason the application and agreement deadlines sit years ahead of the final placing-on-market date rather than trailing close behind it.

Classification decided which deadline applies before Article 110 ever came up

Annex VIII's classification rules settle a device's class long before Article 110 becomes relevant, but that earlier decision is exactly what determines which column of dates a legacy device falls into now. A file that tracks “the IVDR deadline” as one date, rather than deriving it from the device's own Annex VIII class, is one classification error away from tracking the wrong year entirely.

An extension on certification isn't an extension on obligations

Nothing in Article 110's extended timeline suspends the duties that already run against any IVD on the EU market regardless of certificate status: vigilance reporting, the PMPF plan's own reporting cadence, and economic-operator duties keep applying to a legacy device on the extended timeline exactly as they would to one already IVDR-certified. A transition tracker that stops at the certification deadline and treats everything before it as compliance has confused an extension on paperwork for an extension on performance.

Where this meets the rest of the file

A legacy-IVD transition tracker built around the class-based deadlines, the conditions that keep each one attached, and the standing obligations that run independent of certificate status, is previewed in the launch catalog. If your program tracks the Article 110 extension differently, the shelf takes that correction directly.