EU IVDR Transition Deadlines 2027, 2028 and 2029

Table of Contents

• Introduction
• What Regulation (EU) 2024/1860 Actually Changed
• Which Devices Count as Legacy Devices
• The Three End Dates, by IVDR Class
• Class A Non-Sterile Has No Transition at All
• The Two Dated Gates: Application, Then Written Agreement
• The Application Gate
• The Written Agreement Gate
• The IVDD Certificate Trap
• The Conditions That Run for the Whole Period
• What Counts as a Significant Change
• IVDR Obligations That Already Apply to Legacy Devices
• EUDAMED and the Registration Deadlines
• Devices Already in the Supply Chain
• Why a Fourth Extension Is Not a Plan
• What to Do Now, by Scenario
• Self-Declared Class C
• Devices With an IVDD Certificate
• Class B and Class A Sterile
• Six Mistakes We See in Transition Files
• Frequently Asked Questions
• Conclusions

Introduction

The IVDR transition is discussed almost entirely in terms of three dates in December — 2027, 2028 and 2029 — and that framing is the most expensive misunderstanding in the in vitro diagnostics sector right now. Those dates are not deadlines. They are the last day of a transitional period that a manufacturer only holds if a set of conditions has been met continuously, and two of those conditions carry dates that fell long before December of anything.

A device does not lose its transitional status at the end of the period. It loses it on the day a condition fails. For a self-declared class C legacy device, that day was 26 May 2026 if no application was lodged with a notified body, and it is 26 September 2026 if the written agreement with that notified body is not signed. December 2028 is simply what remains available to a manufacturer who cleared both.

This article maps every gate and every end date under Regulation (EU) 2017/746 as amended by Regulation (EU) 2024/1860, explains which set of dates applies to your device — which is not always the set matching its IVDR class — and sets out what has to be true throughout the period rather than at the end of it. If you are working on the dossier rather than the timeline, our guide to IVDR technical documentation covers Annex II section by section.

What Regulation (EU) 2024/1860 Actually Changed

Regulation (EU) 2017/746 has applied since 26 May 2022. Its central change over Directive 98/79/EC was classification: where the Directive listed specific devices in annexes and left most in vitro diagnostics to self-declaration, the IVDR applies the rule-based risk classification of Annex VIII, which pulls the great majority of the market into notified body assessment for the first time. The arithmetic was never going to work. There were not enough designated notified bodies, and the ones that existed could not absorb tens of thousands of dossiers in a single wave.

Regulation (EU) 2024/1860 responded by staggering the transitional periods by risk class and tying them to procedural milestones rather than granting a blanket extension. This is the point that gets lost. The amendment did not give the sector more time; it gave the sector more time conditional on demonstrating that the conformity assessment is genuinely under way. A manufacturer who does nothing until 2028 does not have until 2028. They had until the application gate for their class, and after that the device was no longer lawfully placeable on the EU market.

The same amendment introduced a supply-continuity obligation. Manufacturers who intend to discontinue a device whose absence could cause serious harm or a disruption of care must give advance notice, generally six months, to the competent authority and to the health institutions and healthcare professionals they supply. That obligation exists because the transition itself was expected to remove products from the market. Regulators treated the timeline as a supply risk, not as a paperwork exercise.

Which Devices Count as Legacy Devices

The transitional provisions apply to what the sector calls legacy devices: devices lawfully placed on the EU market under Directive 98/79/EC before 26 May 2022, which continue to be placed on the market after that date. Two populations sit inside that definition and they are treated very differently.

The first is devices that held a certificate issued by a notified body under the IVDD. Under the Directive this was a minority — broadly the Annex II List A and List B devices and devices for self-testing. The second is devices that were self-declared under the Directive, which was most of the market, and which the IVDR now classifies as class D, C, B or A on the basis of the Annex VIII rules.

A device that was never on the EU market before 26 May 2022 is not a legacy device and has no transitional period. It requires full IVDR compliance before it is placed on the market, whatever its class. The same is true of a device that has undergone a significant change in design or intended purpose: the change removes the device from the transitional regime rather than restarting it.

The Three End Dates, by IVDR Class

The end of the transitional period is staggered so that higher-risk devices clear the system first. Class D devices — those intended to detect transmissible agents presenting a high risk of propagation, and devices used to determine infectious load or compatibility for blood, cells and organs — reach the end of their transitional period on 31 December 2027. Class C devices reach it on 31 December 2028. Class B devices, and class A devices placed on the market in sterile condition, reach it on 31 December 2029.

Those are the dates that circulate. What circulates far less is that each of them sits at the end of a chain of two earlier gates, and that a device which missed either gate never had the December date to begin with.

Figure 1 — The IVDR transitional period as a sequence of conditional gates, by risk class

Class A Non-Sterile Has No Transition at All

This is worth stating separately because it is routinely overlooked. Class A non-sterile devices — specimen receptacles, general laboratory instruments, buffers, washing solutions and similar products — are self-assessed under the IVDR without notified body involvement, and precisely because no notified body capacity was needed, no transitional period was granted. Full IVDR compliance, including an EU declaration of conformity referencing the Regulation, technical documentation meeting Annex II and Annex III, and registration obligations, has been required since 26 May 2022. A manufacturer still shipping class A non-sterile product against an IVDD declaration is not late for a future deadline; they are non-compliant now.

The Two Dated Gates: Application, Then Written Agreement

The conditional structure of the extension rests on two milestones, four months apart. Both must be cleared for the transitional period to continue running, and clearing the first without the second is worth nothing.

The Application Gate

By the application date for the relevant class, the manufacturer must have lodged a formal application for conformity assessment with a notified body designated under the IVDR. An enquiry is not an application. A quotation request is not an application. What is required is the submission that starts the notified body’s formal review process, in the form that body requires, with the dossier it requires at that stage.

The Written Agreement Gate

By 26 September of the same year, the manufacturer and the notified body must have signed a written agreement covering the conformity assessment of the device. This is the gate that catches people, because it is not entirely within the manufacturer’s control. Notified bodies have queues, contracting departments and capacity decisions. A manufacturer who lodged an application on the last available day in May, into a body already at capacity, may find that no contract is offered before the September date.

The four-month interval exists to force the queue into the open. An application with no contract behind it is an expression of intent; a signed agreement is a notified body committing resources. The legislator chose to make the second one the condition. If your application is lodged and the agreement is not yet signed, the practical action is not to wait for the notified body’s normal contracting cycle: escalate in writing, ask for the contract to be issued ahead of assessment scheduling, and keep the correspondence. A signed agreement with an assessment scheduled for 2027 preserves the transitional period. An unsigned agreement with an assessment scheduled for next month does not.

The IVDD Certificate Trap

Here is the provision that produces more failed assumptions than any other in the transitional regime. A device that held a certificate issued by a notified body under Directive 98/79/EC follows the class D timeline — application by 26 May 2025, written agreement by 26 September 2025, end of transitional period 31 December 2027 — regardless of the class it now falls into under IVDR Annex VIII.

The logic is that a device already inside the notified body system under the Directive had no capacity excuse. It had a notified body, a relationship and a certification history. The staggered extension was designed for the very large population of previously self-declared devices entering conformity assessment for the first time, not for products already in the queue.

The practical consequence is that classification alone does not tell you your dates. A device that classifies as class B under the IVDR, whose manufacturer therefore assumed a 2029 horizon and a 2027 application gate, has in fact been outside the transitional regime since 2025 if it held an IVDD certificate. We have seen this discovered during due diligence, which is the worst possible moment.

Figure 2 — Which set of dates applies to your device: the decision starts with the certificate, not with the classification

The Conditions That Run for the Whole Period

Beyond the two dated gates, a set of conditions must hold continuously. Failure of any one ends the transitional status on the day it fails, without notice and without a grace period.

The device must continue to comply with Directive 98/79/EC. This is not a formality: the IVDD requirements remain the applicable essential requirements throughout the transition, and a device that has drifted out of compliance with its own IVDD documentation has no transitional status to rely on. There must be no significant change in the design or the intended purpose of the device, which is the most commonly breached condition in practice and is discussed in the next section. The device must not present an unacceptable risk to the health or safety of patients, users or other persons, a condition that gives competent authorities a direct route to remove a device from the transitional regime on safety grounds without waiting for the end date.

Finally, a quality management system meeting Article 10(8) of the IVDR must have been in place since 26 May 2025. This applies whatever the class, including devices that are still years from their end date, and it is the condition that most often exists on paper rather than in operation. A quality system that has been written but never audited internally, whose management review has never been held and whose CAPA process has never closed a record with an effectiveness check, is not a quality system that is in place. Our overview of ISO 13485 sets out what an assessor expects to find.

Figure 3 — Which dates apply by device population, and the four conditions that must remain true throughout

What Counts as a Significant Change

A significant change in design or intended purpose terminates the transitional period for the device. There is no IVDR-specific guidance with the standing that MDCG 2020-3 has on the medical device side, so manufacturers work from the text of the Regulation and by analogy, which means the assessment has to be documented carefully enough to survive being second-guessed later.

Changes to the intended purpose are the clearer case: a new target population, a new clinical indication, a new specimen type, a move from professional use to self-testing or near-patient testing, or an extension of claims that alters the clinical decision the result supports. Any of these is a change of intended purpose and almost always significant.

Design changes are harder. A change to the assay chemistry, to the antibody or primer sequences, to the calibrator or control material traceability chain, to the measuring range, to the cut-off, or to the software algorithm that produces or interprets the result should be presumed significant until an assessment says otherwise. Changes of manufacturing site, packaging changes that do not affect stability, and corrections that do not alter performance sit at the other end. Administrative changes and changes required to maintain compliance with the Directive itself are not significant changes.

The assessment matters more than the conclusion. A competent authority reviewing a legacy device will not be persuaded by an assertion that no significant change occurred; it will ask for the record showing that each change since 26 May 2022 was evaluated against the criteria, by whom, and on what basis. If those records do not exist, the safest assumption is that the transitional status is not defensible.

IVDR Obligations That Already Apply to Legacy Devices

The transitional period suspends the requirement to hold IVDR conformity assessment. It does not suspend the Regulation. Three families of obligation apply to legacy devices now, from the date of application of the IVDR, and they are enforced independently of where a manufacturer sits on the timeline.

Post-market surveillance under the IVDR applies in full: a PMS plan meeting Annex III, a post-market performance follow-up plan inside it, and either a PMS report or a periodic safety update report depending on class, at the frequency the Regulation sets. The obligations are set out in MDCG 2025-10, and the point most often missed is that performance indicators and thresholds are meant to be fixed in advance rather than derived retrospectively from the first year of complaints.

Vigilance applies in full: serious incident and field safety corrective action reporting under Articles 82 to 87, on IVDR timelines, through IVDR channels. And registration applies: the manufacturer, the authorised representative and the importer must be registered as actors, and devices must be registered, on the timelines EUDAMED sets rather than on the timeline of the device’s own transitional period. A person responsible for regulatory compliance under Article 15 is also required now, not from the end date.

EUDAMED and the Registration Deadlines

EUDAMED registration runs on its own clock, decoupled from the device’s transitional period. The actor registration module and the UDI and device registration modules have their own mandatory dates, driven by the Commission notices confirming module functionality rather than by the transitional provisions.

The planning point is that a manufacturer of a class B legacy device with an end date in December 2029 still has EUDAMED obligations falling well before that, and the registration process itself surfaces data the manufacturer may not have assembled: Basic UDI-DI assignment, device model grouping, and the correspondence between what is registered and what is actually on the market. Our guide to EUDAMED registration covers the sequence and the data model.

Devices Already in the Supply Chain

The end of a transitional period governs placing on the market, which is the first making available of a device on the EU market. It does not automatically remove devices that have already been placed. Devices lawfully placed on the market before the end of the transitional period may continue to be made available or put into service.

This is a narrower relief than it appears. It applies to units already placed on the market, not to continued manufacture, and post-market surveillance, vigilance and traceability obligations continue for those units for their full lifetime. Planning a transition around residual stock buys weeks, not years.

Why a Fourth Extension Is Not a Plan

Every extension granted so far was justified by notified body capacity, and each was accompanied by conditions designed to separate manufacturers who were progressing from manufacturers who were waiting. Capacity has improved materially since 2022, more bodies are designated under the IVDR, and the conditional structure of Regulation (EU) 2024/1860 was built precisely so that a further blanket extension would be harder to justify.

More to the point, a regulatory strategy that depends on a future legislative amendment is not a strategy. It is a position with no legal basis, which cannot be documented, cannot be presented to an auditor, and cannot be defended to a customer whose supply is at risk. The manufacturers who came through the MDR transition intact are, almost without exception, the ones who treated the first published date as real.

What to Do Now, by Scenario

The right next action depends entirely on which population your device sits in, and the first task is always to establish that rather than assume it.

Self-Declared Class C

Confirm that an application was lodged with a designated notified body by 26 May 2026 and that a written agreement is signed, or will be signed, by 26 September 2026. If the agreement is not signed, that is the only item that matters this month: the dossier can be imperfect and the assessment can be scheduled for next year, but the contract has to exist. If no application was lodged, the device is already outside the transitional regime, and the question is no longer about the timeline but about whether to withdraw, to complete full IVDR conformity assessment before re-placing, or to discontinue with the notice obligations that entails.

Devices With an IVDD Certificate

Verify against the certificate itself, not against memory or a spreadsheet, whether a notified body issued a certificate under Directive 98/79/EC. If it did, the class D dates applied: application by 26 May 2025, written agreement by 26 September 2025, end of transitional period 31 December 2027. Confirm both were met. If they were, the remaining work is the conformity assessment itself against a 2027 horizon, which is tighter than it sounds once notified body scheduling is factored in.

Class B and Class A Sterile

The application gate is 26 May 2027 and the written agreement gate is 26 September 2027. This is the population with time remaining, and the mistake it makes is spending that time on the technical documentation before securing the notified body. Contract first. Capacity for the 2027 wave will be consumed by manufacturers who booked early, and a complete dossier with no body to assess it is worth nothing on the deadline. In parallel, the Article 10(8) quality system has been required since May 2025, and the performance evaluation work under ISO 20916 and MDCG 2022-2 has the longest lead time of anything in the file.

Six Mistakes We See in Transition Files

The first is treating the December date as the deadline, which this article exists to correct. The second is assuming that IVDR classification determines the timeline, when for IVDD-certified devices it does not. The third is lodging an application and considering the gate cleared, when the written agreement four months later is the operative condition.

The fourth is a quality system that exists as a document set rather than as an operating process, which fails the Article 10(8) condition even though the binder is complete. The fifth is an undocumented history of changes since May 2022, leaving the manufacturer unable to demonstrate that no significant change occurred. The sixth is treating post-market surveillance and vigilance as future obligations, when both have applied to legacy devices since 2022 and are the easiest thing for a competent authority to check without visiting.

Figure 4 — Six findings that recur across IVDR transition files, and what each one costs when it surfaces late

Frequently Asked Questions

Does the transitional period apply automatically?
No. It applies only while every condition holds: the dated application and written agreement gates for the relevant class, continued compliance with Directive 98/79/EC, no significant change in design or intended purpose, no unacceptable risk, and an Article 10(8) quality management system in place since 26 May 2025.

My device is class C under the IVDR but held an IVDD certificate. Which dates apply?
The class D dates. A device certified by a notified body under Directive 98/79/EC follows the 26 May 2025 application gate, the 26 September 2025 written agreement gate and the 31 December 2027 end date, whatever its IVDR classification.

Is lodging the application enough to preserve the transitional period?
No. The written agreement with the notified body must be signed by 26 September of the same year. An application with no signed agreement behind it does not preserve transitional status past that date.

What happens on the day a condition fails?
The device ceases to benefit from the transitional provisions from that date. It can no longer be placed on the EU market unless and until it is fully IVDR compliant. There is no notification, no grace period and no retrospective cure.

Can I still sell stock that is already in the supply chain?
Devices lawfully placed on the market before the end of the transitional period may continue to be made available and put into service. Post-market surveillance, vigilance and traceability obligations continue to apply to those units.

Do class A non-sterile devices have a transitional period?
No. They have required full IVDR compliance since 26 May 2022, because they are self-assessed and no notified body capacity constraint applied.

Will there be another extension?
There is no basis for planning on one. The conditional structure of Regulation (EU) 2024/1860 was designed specifically to separate manufacturers who are progressing from manufacturers who are waiting, and notified body capacity — the justification for every previous extension — has improved.

Does a change of manufacturing site count as a significant change?
Generally no, provided it does not affect the design, the intended purpose or the performance of the device. The assessment still has to be documented; the absence of a record is itself the problem when a competent authority asks.

Conclusions

The IVDR transitional periods are conditional entitlements, not deadlines, and the conditions that end them arrive years before the dates that get quoted. The two questions worth answering this week are which population your device sits in — self-declared or IVDD-certified — and whether the written agreement with a notified body exists as a signed document. Everything else in the file can be sequenced; those two cannot.

Manufacturers who treat the transition as a scheduling problem rather than a documentation problem tend to arrive at the assessment with a notified body slot and an incomplete dossier, which is recoverable. Manufacturers who do the reverse arrive with a complete dossier and no slot, which is not.

This article is part of a series on in vitro diagnostic regulation. The following articles belong to the same series:

• IVDR Explained: What Regulation (EU) 2017/746 Requires
• IVDR Technical Documentation: Annex II Section by Section
• MDCG 2022-2 Explained: Clinical Evidence for IVDs
• MDCG 2025-10: Post-Market Surveillance Under the IVDR
• ISO 20916: Good Study Practice for IVD Performance Studies