EU’s IVDR Class C Notified-Body Deadline Passes

A compliance deadline that most of the industry has been warned about since last year quietly passed on 26 September 2026: the date by which manufacturers of Class C self-declared in vitro diagnostics had to have a signed, dated Notified Body agreement in hand to keep their extended runway to the IVDR's full 2028 deadline. There is no news conference for a deadline like this — only a before and an after. Regulatory News could not find reporting on how many manufacturers made it and how many did not; what is confirmed, across the regulation itself and independent professional sources describing it, is what the deadline requires and what missing it costs.

Why this staged transition exists

The shift from the old In Vitro Diagnostic Directive to the IVDR dramatically expanded which diagnostics need independent Notified Body review: under the Directive, roughly 15 to 20 percent of IVDs required it; under the Regulation, an estimated 80 to 90 percent now do. That jump created a Notified Body capacity crunch severe enough that EU regulators warned of possible diagnostic test shortages if legacy devices were forced off the market before review capacity caught up. Regulation (EU) 2024/1860, published in the Official Journal on 9 July 2024, responded with a staged bridge for legacy devices: quality-system compliance first, then a formal application, then a signed contract, each with its own deadline, each required to keep the extended transition to 2028 alive. Eligibility also requires that the device is a genuine legacy product — covered by an IVDD declaration of conformity drawn up before 26 May 2022 — with no significant change to its design or intended purpose and no unacceptable risk to health or safety.

The deadline that just passed

26 September 2026 was the last of the three checkpoints: manufacturers needed a written agreement with a Notified Body, signed and dated, not merely a submitted application or an ongoing negotiation. Class C is described in professional guidance on the transition as the most common IVD risk class, which means the population affected by this checkpoint is large. A manufacturer that cleared the first two milestones but does not have a countersigned contract as of 26 September has, in effect, lost the statutory bridge: it cannot rely on the 31 December 2028 deadline, and its self-declared IVDD basis for staying on the market becomes legally insufficient once the transition period it was relying on no longer applies to it.

What comes next for a device that missed it

There is no further extension built into the regulation for this cohort. A device that missed 26 September must pursue full IVDR conformity assessment through the ordinary process — and Notified Bodies, according to consultancy figures citing the most recent Notified Bodies survey (from around March 2026), had roughly 3,634 applications on file against about 2,194 certificates issued, with average review times cited at 13 to 18 months. A fresh application filed today would not be expected to clear before mid-to-late 2027 at the earliest, leaving an open window in which the device's market status is, at minimum, uncertain. Regulatory News found no Commission or MDCG guidance yet addressing manufacturers who missed the cutoff, and no post-deadline reporting on compliance rates; both are worth watching in the weeks ahead.

What to check today

• Confirm, device by device, that any Class C self-declared legacy IVD has a Notified Body agreement signed and dated on or before 26 September 2026 — a submitted application or a negotiation in progress does not satisfy the checkpoint.
• Audit the portfolio for anything that fell through the cracks between the 26 May 2026 application deadline and this contract deadline.
• For any device that missed it, prepare a market-withdrawal or alternative-supply contingency plan rather than assuming a further grace period.
• Watch for European Commission or MDCG guidance addressing manufacturers who missed the cutoff, and for updated Notified Body capacity figures as this cohort's applications compete for review slots into 2027.

Frequently asked questions

What deadline passed on 26 September 2026?

The date by which Class C self-declared legacy IVD manufacturers needed a signed, dated Notified Body agreement in place to keep the extended IVDR transition running to 31 December 2028, under Regulation (EU) 2024/1860.

What were the earlier milestones?

An IVDR-compliant quality management system by 25 May 2025, and a formal Notified Body application by 26 May 2026 — the same regulation's first two checkpoints for this cohort.

What happens to a device that missed it?

It loses the extended-transition benefit, cannot rely on the 2028 deadline, and risks having to withdraw from the EU market while pursuing full IVDR certification through a Notified Body backlog running an estimated 13 to 18 months per application.

What should RA/QA teams do now?

Verify that Notified Body agreements for every Class C self-declared legacy device were actually signed and dated by 26 September 2026, and build a contingency plan for any device that was not.