IVDR Transition Deadlines: The Conditions That End Them

The IVDR transition deadlines most manufacturers can name — 31 December 2027, 2028 and 2029 — are the least dangerous dates in Article 110. They are the end of the road. The dates that actually remove devices from the market fall years earlier, and one of them is weeks away.

Article 110 of Regulation (EU) 2017/746, as rewritten by Regulation (EU) 2024/1860, does not simply extend the deadline for legacy in vitro diagnostic devices. It grants an extension conditional on six things, two of which have their own dates. Miss one and the extension never applied to that device.

The two brackets

Article 110 splits legacy devices into two groups, and the group decides the end date.

Article 110(3a) covers devices holding a certificate issued under Directive 98/79/EC that is valid by virtue of Article 110(2). Those may be placed on the market until 31 December 2027.

Article 110(3b) covers the larger and more exposed group: devices for which the Directive’s conformity assessment did not require a notified body, for which a declaration of conformity was drawn up before 26 May 2022, and which now do require notified body involvement under the Regulation. Those get staggered dates by class.

Note what is not in that table. Class A non-sterile devices are not in Article 110(3b) at all, because they never needed a notified body under either instrument. They needed to be IVDR-compliant from 26 May 2022.

The six conditions

Article 110(3c) permits those devices on the market only if all of the following are met, continuously:

1. the devices continue to comply with Directive 98/79/EC;
2. there are no significant changes in the design and intended purpose;
3. the devices do not present an unacceptable risk to health or safety;
4. no later than 26 May 2025, the manufacturer has put in place a quality management system in accordance with Article 10(8);
5. the manufacturer or authorised representative has lodged a formal application with a notified body under Annex VII Section 4.3, by the applicable date;
6. the notified body and the manufacturer have signed a written agreement under Annex VII Section 4.3, by the applicable date.

Conditions 5 and 6 are two distinct steps in the same Annex VII section, and Article 110 attaches a separate deadline to each.

The dates that actually bite

Read the two columns together. Lodging an application is something a manufacturer does alone. Signing a written agreement requires a notified body that is willing and able to sign — and notified body capacity under the IVDR is the sector’s binding constraint, not a formality. Four months separates the two dates, and a manufacturer who applied on the last permitted day has left themselves no margin at all.

For class C devices, that agreement deadline is 26 September 2026. If it is not signed by then, the device cannot be placed on the market from 27 September — not from 31 December 2028.

The expired-certificate rescue

Article 110(2) does something easy to miss. A Directive certificate issued from 25 May 2017 that was still valid on 26 May 2022 and has not been withdrawn continues to be valid until 31 December 2027.

A certificate that expired before 9 July 2024 is also considered valid until that date — but only if one of two things happened before the expiry: the manufacturer and a notified body signed a written agreement under Annex VII Section 4.3 second subparagraph, or a competent authority granted a derogation under Article 54(1) or required an assessment under Article 92(1).

If neither happened, the certificate is simply expired and the device has no transitional basis.

Significant change is a cliff, not a process

Condition 2 has no middle ground. There is no procedure for “significant change approved” and no notified body sign-off that rescues it. If a change to the design or intended purpose is significant, the device leaves the transitional regime and requires full IVDR conformity before it can be placed on the market again.

That makes the assessment itself the control. It should be written as though it will be challenged, recording what was considered and rejected rather than only the conclusion — and it should be done before the change is implemented, not discovered afterwards.

Condition 1 works the same way from the other direction: a change that takes the device out of compliance with Directive 98/79/EC ends the extension just as surely.

Legacy devices are already in the IVDR post-market regime

The most commonly missed provision in the whole article is Article 110(3d). By derogation from the transitional arrangement, the Regulation’s requirements on post-market surveillance, market surveillance, vigilance, and registration of economic operators and of devices apply to Article 110(3a) and (3b) devices instead of the corresponding Directive requirements.

So a legacy device is a hybrid: Directive conformity, IVDR surveillance. In practice that means a device relying on the transition needs, today:

• a post-market surveillance system under Article 78 and a plan meeting Annex III;
• a PSUR at least annually for class C and D, or a post-market surveillance report for class A and B;
• serious incident and field safety corrective action reporting under Article 82, on the 2, 10 and 15-day clocks;
• trend reporting under Article 83, with the methodology and observation period stated in the plan;
• economic operator and device registration.

Article 110(11) adds one more: Article 10a, the supply-interruption notification introduced by Regulation (EU) 2024/1860, also applies to these devices.

Building a transition plan on the assumption that “the Directive applies until 2028” understates the obligation by a wide margin.

Who supervises a legacy device

Article 110(3e) allocates surveillance during the transition. The notified body that issued the Directive certificate remains responsible for appropriate surveillance of the devices it certified, unless the manufacturer has agreed with a body designated under Article 38 that the latter will take it on.

Then a handover date: no later than 26 September 2025, the notified body that signed the Article 110(3c)(f) written agreement becomes responsible for surveillance of the devices covered by it. Where the agreement covers a device intended to substitute a legacy device, surveillance is conducted in respect of the device being substituted.

The transfer arrangements must be defined in an agreement between the manufacturer and the incoming notified body — and, where practicable, the outgoing one. The incoming body is not responsible for conformity assessment work carried out by the outgoing body.

Discontinuation is a regulated act

A device you have decided not to transition will stop being supplied on a known date. That is an anticipated discontinuation under Article 10a, and where it is reasonably foreseeable that it could cause serious harm or a risk of serious harm to patients or public health in one or more Member States, the manufacturer must notify — at least six months in advance, other than in exceptional circumstances.

The notification goes to the competent authority of the Member State where the manufacturer or its authorised representative is established, and to the economic operators, health institutions and healthcare professionals directly supplied. Those recipients then cascade it down the supply chain.

For diagnostics the harm assessment is not simply “is there an alternative”. Laboratories cannot substitute one assay for another freely: reference intervals differ, results are not numerically interchangeable, and patient monitoring series break. An interruption that looks manageable on availability grounds can still cause harm on continuity grounds.

A condition audit, not a status report

The useful form of a transition tracker takes an evidence reference for each condition, not a Yes. “QMS in place” is an assertion; “QMS certificate [ref], dated before 26 May 2025” is evidence. The distinction matters because the conditions are tested retrospectively, by someone who was not there.

For each device, record: the Article 110 category and therefore the end date; the status of all six conditions with references; both Annex VII Section 4.3 milestone dates; who holds surveillance responsibility; whether the Article 110(3d) obligations are actually running; and the exit route — full IVDR conformity, a substitute device, or planned discontinuation — with a target date that lands before the end date.

Review it monthly while any condition date is within twelve months. The dates do not move and the consequences are absolute.

Our EU IVDR Toolkit includes a legacy device transition plan and a transition deadline and condition tracker built around exactly that, with worked examples of a device whose written agreement is unsigned two months out and one whose significant change assessment ended the extension. For the wider picture, see our guide to the EU IVDR.

Frequently asked questions

What are the IVDR transition deadlines?

Placing on the market ends 31 December 2027 for devices with a Directive certificate and for class D devices that previously self-declared, 31 December 2028 for class C, and 31 December 2029 for class B and class A sterile devices. All of those depend on the six Article 110(3c) conditions being met continuously.

What happens on 26 September 2026?

It is the deadline for class C legacy devices to have a signed written agreement with a notified body under Annex VII Section 4.3. The formal application deadline for those devices was 26 May 2026. If the agreement is not signed, the Article 110 extension fails and the device cannot be placed on the market.

Can a missed condition be remedied?

No. Article 110(3c) has no remediation procedure and no grace period. If a condition is not met, the extension does not apply to that device and full IVDR conformity is required before it can be placed on the market.

Do legacy IVDs need IVDR post-market surveillance?

Yes. Article 110(3d) applies the Regulation’s post-market surveillance, market surveillance, vigilance and registration requirements to transitional devices instead of the Directive’s. Article 110(11) also applies Article 10a on supply interruptions.

Are class A devices covered by the transition?

Only class A devices placed on the market in sterile condition, which fall in the 31 December 2029 bracket alongside class B. Class A non-sterile devices are self-declared under both instruments and were never in Article 110(3b); they needed to be IVDR-compliant from 26 May 2022.