IVDR Transition Periods: The 2027, 2028 and 2029 Deadlines for Legacy IVDs, the Conditions of Regulation 2024/1860 and What Ends When

The IVDR, Regulation (EU) 2017/746, has applied since 26 May 2022 and is directly applicable in every member state. Its transitional provision is Article 110; the MDR counterpart is MDR Article 120, and the deadlines of both regulations sit side by side under EU MDR and IVDR.

Below follow the end dates by group, the six conditions, MDCG 2022-6 on significant changes, the IVDD certificates, the missing sell-off date, the duties during the transition, the evidence to keep and the pending revision.

What Is the IVDR Transition Period?

The IVDR transition period is the time, set by Article 110 of Regulation (EU) 2017/746, during which an IVD with a valid IVDD certificate, or a self-declared IVD whose declaration of conformity was drawn up before 26 May 2022 and that now needs a notified body, may still be placed on the market after the IVDR became applicable on 26 May 2022. The second group covers self-declared IVDD devices that are class B, C, D or sterile class A under the IVDR (IVDR Article 110(3b), in the consolidated IVDR on EUR-Lex). "Legacy device" is a term of MDCG 2021-25 rev.1 and MDCG 2022-8, not an IVDR Article 2 definition.

The end date limits placing on the market only; units already placed are covered in the sell-off section below. The other obligations and deadlines of the regulation are set out under IVDR (Regulation (EU) 2017/746).

How the Deadlines Moved from 2024 to 2027, 2028 and 2029

The IVDR as adopted ended the transition on 26 May 2024, with IVDD certificates valid until 27 May 2024. Regulation (EU) 2022/112, adopted on 25 January 2022 and in force since 28 January 2022, staggered those dates to 26 May 2025 (certificates and class D), 26 May 2026 (class C) and 26 May 2027 (class B and sterile class A), and set sell-off dates. Regulation (EU) 2023/607, in force since 20 March 2023, deleted the sell-off dates.

Regulation (EU) 2024/1860, adopted on 13 June 2024 and in force since its publication on 9 July 2024, replaced the end dates with 31 December 2027, 31 December 2028 and 31 December 2029 and tied each date to the conditions now set out in IVDR Article 110.

What Ends When: Every IVDR Transition Date in One Table

Fourteen dates decide the IVDR transition as of 6 November 2026: nine lie in the past, the next deadlines are the class B and sterile class A application on 26 May 2027 and written agreement on 26 September 2027, and one rule has no end date at all, the making available of units already placed on the market. Every end date in the table applies only under the conditions of IVDR Article 110 as amended by Regulation (EU) 2024/1860.

Showing 10 of 10

In-house devices have dates of their own: IVDR Article 5(5) points (b), (c) and (e) to (i) have applied since 26 May 2024 (Article 113(3)(i), inserted by Regulation (EU) 2022/112), and point (d) applies from 31 December 2030 (Article 113(3)(j) as amended by Regulation (EU) 2024/1860); the conditions are covered under in-house devices under the IVDR.

Devices with an IVDD Certificate and Self-Declared Class D: 31 December 2027

IVDR Article 110(3a) sets 31 December 2027 for every device covered by a valid IVDD certificate, whatever its IVDR class, and Article 110(3b)(a) sets the same date for self-declared devices that are class D under the IVDR. The certificates concerned are those for devices in IVDD Annex II List A or List B and the design-examination certificates for self-tests; both groups depend on the conditions set out below.

The same day is also the MDR end date for class III and class IIb implantable legacy devices, except the listed items, under the conditions of MDR Article 120(3c).

Self-Declared Class C: 31 December 2028

Self-declared legacy IVDs that are class C under the IVDR may be placed on the market until 31 December 2028 (IVDR Article 110(3b)(b)), provided the conditions are met. This group includes legacy companion diagnostics that were self-declared under the IVDD. Its formal application was due by 26 May 2026 and its written agreement by 26 September 2026; both dates have passed. The definition, the class and the medicines-authority consultation are covered under companion diagnostics under the IVDR.

Self-Declared Class B and Sterile Class A: 31 December 2029

Self-declared legacy IVDs that are class B or sterile class A under the IVDR may be placed on the market until 31 December 2029 (IVDR Article 110(3b)(c)).

This is the only group with open condition dates as of 6 November 2026: the formal application is due by 26 May 2027 and the written agreement by 26 September 2027 (IVDR Article 110(3c)(e)(iii) and (f)(iii)). Its quality management system deadline of 26 May 2025 has already passed, as for every other legacy IVD.

Which Legacy IVDs Get No Transition at All?

Class A non-sterile IVDs and devices covered by neither an IVDD certificate nor an IVDD declaration of conformity drawn up before 26 May 2022 have no transitional period: the IVDR has applied to them since 26 May 2022 (Commission Q&A on Regulation (EU) 2024/1860, Q1). The Q&A of the Commission services of July 2024 sets out this group in its first answer.

A class A non-sterile IVD needs no notified body and carries no notified-body number. Its manufacturer declares conformity under the IVDR, as described under self-certification for class A.

Which Class Decides Between 2027, 2028 and 2029?

For self-declared legacy IVDs the class under the seven rules of IVDR Annex VIII decides the end date, not the IVDD list; for IVDD-certified devices the class does not matter, as all end on 31 December 2027. The two sources for that class are listed below.

• The IVDR classes A, B, C and D (IVDR Article 47(1)) under the seven rules of Annex VIII Section 2, explained under IVDR classification rules.
• An indicative class with the Annex VIII rule behind it, from the medical device class finder.

The Conditions of Regulation 2024/1860

A legacy IVD benefits from its 2027, 2028 or 2029 end date only if the conditions of IVDR Article 110, as amended by Regulation (EU) 2024/1860, are all met: three concern the device and three concern the manufacturer, whose quality management system was due by 26 May 2025 for every legacy IVD and whose notified-body deadlines are staggered by class. The table gives the six conditions with their provision, deadline and status; the amending act is published on EUR-Lex as Regulation (EU) 2024/1860.

Conditions on the Device: Continued IVDD Compliance, No Significant Change, No Unacceptable Risk

The device must continue to comply with the IVDD, must undergo no significant change in design or intended purpose, and must present no unacceptable risk to health or safety. These three conditions carry no deadline: they apply every day from 26 May 2022 until the end date of the group.

Which changes count as significant is the subject of MDCG 2022-6, set out in the next section with its charts and examples.

Conditions on the Manufacturer: Quality Management System, Application and Written Agreement by Class

By 26 May 2025 every manufacturer of a legacy IVD had to put in place a quality management system in accordance with IVDR Article 10(8) (Article 110(3c)(d)), whatever the class.

The notified-body steps are staggered. A formal application had to be lodged by 26 May 2025 for IVDD-certified and class D devices, by 26 May 2026 for class C, and is due by 26 May 2027 for class B and sterile class A (Article 110(3c)(e)(i) to (iii)). The written agreement follows by 26 September of the same years for the same groups (Article 110(3c)(f)(i) to (iii)).

As of 6 November 2026, only the class B and sterile class A application and agreement dates are still open.

What Happens When a Condition Is Not Met?

A device left out of a formal application loses the transition on the application deadline of its group (Commission Q&A on Regulation (EU) 2024/1860, Q3).

A significant change in design or intended purpose, or a loss of IVDD compliance, ends the transition for the device concerned, whatever its end date. A finding of unacceptable risk under IVDR Articles 89 and 90 also ends the transition for that device (Q&A Q11).

Significant Changes to Legacy IVDs: What MDCG 2022-6 Explains

MDCG 2022-6, published in May 2022, is the MDCG guidance on which changes to a legacy IVD count as significant changes in design or intended purpose; it is not legally binding, and as of 6 November 2026 it has not been revised to Regulation (EU) 2024/1860, so it still refers to Article 110(3) as amended by Regulation (EU) 2022/112. The MDCG 2022-6 document is published on the Commission's health website.

Its annex holds a main chart and five charts: A (intended purpose), B (design), C (software), D (ingredients and materials) and E (sterilisation). Notified bodies take MDCG guidance into consideration under IVDR Annex VII Section 1.6.2. Every guidance document on the transition and on other topics is listed under MDCG guidance documents.

Intended-Purpose and Design Changes in the MDCG 2022-6 Examples

MDCG 2022-6 treats a new analyte or genotype, a new function such as screening, monitoring or diagnosis, a new specimen type and a move from professional to lay use as significant changes of intended purpose. The table sets its examples against the chart that covers them.

A change of operating principle, such as a move from immunofluorescence to ELISA, is the design example MDCG 2022-6 treats as significant. The examples illustrate the charts and do not list every possible change.

How Regulation 2024/1860 Extended IVDD Certificates

An IVDD certificate issued from 25 May 2017, still valid on 26 May 2022 and not withdrawn remains valid until 31 December 2027 (IVDR Article 110(2) second subparagraph), and the devices it covers may be placed on the market until that date only if the conditions are met. Certificates issued under IVDD Annex VI are the exception: they became void on 27 May 2025 at the latest (Article 110(2) first subparagraph).

The expiry date printed on an IVDD certificate does not show this extension by law. Certificate types and their verification are covered under MDR and IVDR certificates.

Certificates That Expired Before 9 July 2024

An IVDD certificate that expired before 9 July 2024, the day Regulation (EU) 2024/1860 entered into force, counts as valid only if a written agreement was signed before it expired, or a competent authority granted a derogation under IVDR Article 54(1) or required the conformity assessment under Article 92(1).

No Sell-Off Date: Units Already Placed on the Market

There is no sell-off date for IVDs since Regulation (EU) 2023/607 replaced IVDR Article 110(4) with effect from 20 March 2023: a device lawfully placed on the market before its end date may continue to be made available or put into service afterwards. A distributor may therefore still supply in 2030 a self-declared class B unit placed on the market before 31 December 2029.

The same act made the same change to MDR Article 120(4), so neither regulation has a sell-off date.

Notified-Body Surveillance and Other Duties During the Transition

During the transition, the notified body that signed the written agreement is responsible for the appropriate surveillance of certified legacy IVDs at the latest from 26 September 2025 (IVDR Article 110(3e)), and IVDR Article 110(3d) puts every legacy IVD under the IVDR rules on post-market surveillance, market surveillance, vigilance and registration. The five duties and exceptions are listed below.

• Appropriate surveillance: not for self-declared legacy IVDs (Commission Q&A on Regulation (EU) 2024/1860, Q12); MDCG 2022-15 (September 2022) covers it, and MDCG 2022-8 (May 2022) covers IVDR requirements for legacy devices, neither revised to Regulation (EU) 2024/1860 as of 6 November 2026.
• Self-test design-examination certificates (IVDD Annex III Section 6): no Article 110(3e) surveillance; the IVDR notified body handles change notifications from 26 September 2025 (Q&A Q12); see self-tests under the IVDR.
• Notice of interruption or discontinuation: at least 6 months ahead, since 10 January 2025 (IVDR Article 110(11), inserted by Regulation (EU) 2024/1860), under the rules on supply interruption under Article 10a of the IVDR.
• Post-market surveillance and vigilance: see post-market surveillance under the IVDR and vigilance under the IVDR.
• Registration and identification: EUDAMED registration in the windows of the EUDAMED timeline; legacy IVDs are not subject to the requirements on UDI under the IVDR (Q&A Q9.2).

How to Prove and Keep the Transition Status

Keep the evidence of the transition status on file for every legacy IVD, because neither the IVDD certificate nor the declaration of conformity shows that the transition still applies. The six steps below build that file.

1. Keep the valid IVDD certificate, or the IVDD declaration of conformity drawn up before 26 May 2022.
2. Keep copies of the formal application and of the signed written agreement, with their dates.
3. Request the optional notified-body confirmation letter on the NBCG-Med template of 26 July 2024 (Regulation (EU) 2024/1860 version), published by the Commission, in principle at no extra cost (Commission Q&A on Regulation (EU) 2024/1860, Q5).
4. Obtain a certificate of free sale for export where one is needed, from the member state of the manufacturer's or authorised representative's registered place of business (IVDR Article 55(1)).
5. Keep the Commission Q&A of July 2024 and MDCG 2022-6, 2022-8 and 2022-15 at hand.
6. Plan the IVDR certificate before the end date, including the IVDR performance evaluation (IVDR Article 56(3)).

Is a Further Extension of the IVDR Deadlines Proposed?

The Commission's proposal for a targeted revision, COM(2025) 1023 of 16 December 2025 (procedure 2025/0404(COD)), does not change the 2027, 2028 and 2029 end dates; it is pending, and as of 6 November 2026 the European Parliament lists it at the stage "Awaiting committee decision" in its public health committee (SANT). Its past procedural events include the committee referral announced on 25 March 2026 and the draft report of rapporteur Oliver Schenk (EPP) of 30 June 2026, as recorded in the legislative observatory file.

The proposal would let legacy orphan IVDs that meet the orphan criteria, confirmed by an expert panel opinion, stay on the market after the end dates without a valid certificate and without the CE marking. It would let procedures pending, and certificates issued, before 6 months after its entry into force continue under the current rules, and sterile class A IVDs would no longer require notified-body involvement. Every adopted act and the proposal are tracked under MDR and IVDR amendments.

IVDR Transition Questions

Five questions come up about the IVDR transition dates.

Did the IVDR transition end on 26 May 2025?

No: 26 May 2025 was the quality management system deadline for all legacy IVDs and the application deadline for IVDD-certified and self-declared class D devices; the end dates are 31 December 2027, 2028 and 2029 by group, but the transition ended that day for devices of those two groups left out of a formal application (Commission Q&A on Regulation (EU) 2024/1860, Q3).

Does the MDR use the same end dates?

No: the MDR legacy end dates are 31 December 2027 (class III and class IIb implantable, except the listed items) or 31 December 2028 (the others), under the conditions of MDR Article 120(3c), whose deadlines passed in 2024. The MDR dates are set out under MDR transition period.

Is the class C application deadline still open?

No: the class C application was due by 26 May 2026 and the written agreement by 26 September 2026 (IVDR Article 110(3c)(e)(ii) and (f)(ii)), and both dates have passed.

Can a self-declared class B device still use the extended transition?

Yes, if the conditions are met: the quality management system was due by 26 May 2025, the formal application is due by 26 May 2027 and the written agreement by 26 September 2027 (IVDR Article 110(3c)(d), (e)(iii) and (f)(iii)).

Do the dates of Regulation 2022/112 still apply?

No: Regulation (EU) 2024/1860 replaced the 2025, 2026 and 2027 end dates of Regulation (EU) 2022/112, and Regulation (EU) 2023/607 had already deleted its sell-off dates. The directive and the regulation are compared under IVDD vs IVDR.