MDR Transition Period: The 2027 and 2028 Deadlines, the Conditions of Regulation 2023/607 and What Ends When

The MDR, Regulation (EU) 2017/745, has applied since 26 May 2021 and is directly applicable in every member state. Its transitional provision is Article 120; the IVDR counterpart is IVDR Article 110, and the dates of both sit side by side under EU MDR and IVDR.

Below follow the end dates and the class that decides between them, the five conditions, the extension of Directive certificates, the missing sell-off date, the duties during the transition, the evidence to keep and the pending revision.

What Is the MDR Transition Period?

The MDR transition period is the time, set by Article 120 of Regulation (EU) 2017/745, during which a legacy device with a valid MDD or AIMDD certificate, or a self-declared device that now needs a notified body, may still be placed on the market or put into service after the MDR became applicable on 26 May 2021. The second group means class I devices whose declaration of conformity was drawn up before 26 May 2021 and that need a notified body under the MDR. A device that stays class I has no transition: the MDR has applied to it since 26 May 2021 (MDR Article 123(2), in the consolidated MDR on EUR-Lex).

The end date stops placing on the market and putting into service (MDR Article 120(3)), not the making available of units already placed (MDR Article 120(4)). The other obligations and deadlines of the EU MDR are set out under EU MDR (Regulation (EU) 2017/745).

How the Deadlines Moved from 2024 to 2027 and 2028

The original MDR end date for legacy devices was 26 May 2024, with a sell-off date of 27 May 2025. Regulation (EU) 2020/561, in force since 24 April 2020, moved the MDR date of application to 26 May 2021 and kept the 26 May 2024 end date. Regulation (EU) 2023/607, adopted on 15 March 2023 and in force since its publication on 20 March 2023, replaced that end date with 31 December 2027 and 31 December 2028, tied both dates to the five conditions of Article 120(3c) and deleted the sell-off date.

Regulation (EU) 2024/1860, in force since 9 July 2024, left the MDR end dates as they were; it deleted Article 120(8) and added Article 120(13) on supply interruption.

What Ends When: Every MDR Transition Date in One Table

Ten dates decide the MDR transition as of 6 November 2026: seven lie in the past, the next end date is 31 December 2027, and one rule has no end date at all, the making available of units already placed on the market. The table lists each date with the devices concerned, its legal basis and its status on 6 November 2026; both end dates apply only under the five conditions of Article 120(3c).

Products without an intended medical purpose listed in MDR Annex XVI follow their own transition in Implementing Regulation (EU) 2022/2346 as amended by Implementing Regulation (EU) 2023/1194, not the dates of Article 120. Their groups and dates are covered under Annex XVI MDR.

Class III and Class IIb Implantable Devices: 31 December 2027

MDR Article 120(3a)(a) sets 31 December 2027 for class III devices and for class IIb implantable devices, provided the five conditions of Article 120(3c) are met. The same point excludes sutures, staples, dental fillings, dental braces, tooth crowns, screws, wedges, plates, wires, pins, clips and connectors, which move to 31 December 2028 although they are class IIb implantable.

Delegated Regulation (EU) 2026/1359, adopted on 20 March 2026 and in force since 19 July 2026, replaced the second subparagraph of MDR Article 52(4) and added 23 class IIb implant types whose technical documentation is assessed per generic device group. The Article 120(3a)(a) list is unchanged, so a class IIb implantable legacy device of one of the 23 added types keeps the 31 December 2027 end date.

All Other Classes and Up-Classified Devices: 31 December 2028

31 December 2028 applies to the other class IIb devices, to class IIa, Is and Im devices (MDR Article 120(3a)(b)) and to self-declared MDD devices with a declaration of conformity drawn up before 26 May 2021 that need a notified body under the MDR (Article 120(3b)). The Article 120(3b) group consists of up-classified devices, such as former class I devices that move to a higher class, class Ir devices and much of the software that was class I under the MDD. Both groups depend on the same five conditions as the 2027 group.

Class III Custom-Made Implants: The Period That Ended on 26 May 2026

The derogation of MDR Article 120(3f) for class III custom-made implantable devices without the certificate of Article 52(8) ended on 26 May 2026. It covered manufacturers that had lodged an application with a notified body by 26 May 2024 and signed a written agreement by 26 September 2024. The Annex XIII statement and the procedure for custom-made devices under the MDR are covered under custom-made devices under the MDR.

Which Class Decides Between 2027 and 2028?

The class under the MDR Annex VIII rules decides whether 2027 or 2028 applies, not the class the device had under the MDD (Commission Q&A on Regulation (EU) 2023/607, Q4). The Q&A of the Commission services separates the two uses of class below.

• End date: the MDR class under the 22 rules of Annex VIII Chapter III (classes I, IIa, IIb and III, MDR Article 51); see the MDR classification rules of Annex VIII and, for an indicative result, the medical device class finder.
• Class-dependent MDR obligations, such as the periodic safety update report and the post-market surveillance report: the MDD class (Q&A Q4; MDCG 2021-25 rev.1, October 2024, section 3.1).

The Five Conditions of Regulation 2023/607

A legacy device benefits from the 2027 or 2028 end date only if all five conditions of MDR Article 120(3c), inserted by Regulation (EU) 2023/607, are met: three concern the device and two concern the manufacturer, and both of the manufacturer's deadlines passed in 2024. The table gives each condition with its letter, deadline and status; the amending act itself is published on EUR-Lex as Regulation (EU) 2023/607.

Conditions on the Device: Directive Compliance, Unchanged Design and Purpose, No Unacceptable Risk

Article 120(3c)(a) to (c) require that the device continues to comply with the MDD or AIMDD, undergoes no significant change in design or intended purpose and presents no unacceptable risk to health or safety. They carry no deadline and apply until the end date.

MDCG 2020-3 rev.1 explains which changes count as significant; it is guidance, not law. No new Directive certificates are issued during the transition, but a notified body may confirm corrections or non-significant changes in writing (Commission Q&A on Regulation (EU) 2023/607, Q7; MDCG 2020-3 rev.1, sections 3 and 4.1). How changes are judged, and which MDR obligations already apply, is set out under legacy devices under the MDR.

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

By 26 May 2024 the manufacturer had to put in place a quality management system in accordance with MDR Article 10(9) and lodge a formal application with a notified body (Article 120(3c)(d) and (e)), and by 26 September 2024 the notified body and the manufacturer had to sign a written agreement.

The application could come from the manufacturer or its authorised representative. It needed no full review before the agreement and no technical documentation for each device, only a list of the devices and substitutes and the quality management system documentation (Commission Q&A on Regulation (EU) 2023/607, Q8). Points (b), (e) and (f) of Article 10(9) need not be fully met for legacy devices; the system addresses how compliance will be achieved (MDCG 2021-25 rev.1, section 3.2; Q&A Q11.1).

Applications lodged before 20 March 2023 remain valid (Q&A Q12). Implementing Regulation (EU) 2026/977 applies from 25 February 2027; under its Article 8(1), its Articles 1 to 3 do not apply where the written agreement was signed before that date. The time limits of that act are explained under notified body fees and timelines.

What Happens When a Condition Is No Longer Met?

A manufacturer that lodged no application by 26 May 2024 lost the transition on that date, and its certificates that expired between 20 March 2023 and 26 May 2024 counted as valid only until then (Commission Q&A on Regulation (EU) 2023/607, Q3). Withdrawing an application after the deadline ends the transition, unless the file moves at the same time to another notified body; after a refusal, that move is not possible (Q&A Q9.1).

A significant change, a loss of Directive compliance or an unacceptable risk ends the transition for the device concerned, whatever its end date.

How Regulation 2023/607 Extended Directive Certificates

Regulation (EU) 2023/607 extended MDD and AIMDD certificates by law: a certificate issued from 25 May 2017, still valid on 26 May 2021 and not withdrawn remains valid until the end date of its class, 31 December 2027 or 31 December 2028, subject to the five conditions (MDR Article 120(2)). Certificates under MDD Annex IV and AIMDD Annex 4 are the exception: they became void on 27 May 2022 at the latest (Article 120(2) first subparagraph).

The expiry date printed on a certificate does not show this extension by law; the proof section below lists the evidence, and certificate types and their verification are covered under MDR and IVDR certificates.

Certificates That Expired Before 20 March 2023

A certificate that expired before 20 March 2023 counts as valid only if a written agreement was signed before it expired, or a competent authority granted a derogation under MDR Article 59(1) or required the conformity assessment under Article 97(1). The cut-off is the entry into force of Regulation (EU) 2023/607. A derogation or requirement decided after 20 March 2023 does not revive an expired certificate (Commission Q&A on Regulation (EU) 2023/607, Q6.1).

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

There is no sell-off date for medical devices since Regulation (EU) 2023/607 deleted it with effect from 20 March 2023: a unit lawfully placed on the market before its end date may continue to be made available afterwards, subject only to its shelf life or expiry date (MDR Article 120(4); Commission Q&A on Regulation (EU) 2023/607, Q18).

The same deletion covered IVDR Article 110(4), so neither regulation has a sell-off date, and units of legacy IVDs placed before their end dates follow the same rule. A distributor may therefore still supply in 2029 a unit placed on the market before 31 December 2028, within the unit's shelf life.

Notified-Body Surveillance and Other Duties During the Transition

During the transition, the notified body that signed the written agreement carries out the appropriate surveillance of certified legacy devices (MDR Article 120(3e)), MDR Article 120(13) applies the Article 10a supply-interruption duty to them, and Article 120(3d) puts them under the MDR rules on post-market surveillance, market surveillance, vigilance and registration. The four duties are listed below.

• Appropriate surveillance: by the notified body that signed the agreement, at the latest from 26 September 2024; it does not apply to self-declared devices (Commission Q&A on Regulation (EU) 2023/607, Q13).
• Notice of interruption or discontinuation: at least 6 months ahead, since 10 January 2025, under the rules on supply interruption under Article 10a of the MDR, inserted by Regulation (EU) 2024/1860.
• Post-market surveillance and vigilance: under the MDR rules, as explained under post-market surveillance under the MDR and vigilance under the MDR.
• Registration of economic operators and devices: in EUDAMED, in the windows set out in the EUDAMED timeline.

How to Prove and Keep the Transition Status

Keep the evidence of the transition status on file for every legacy device, because the Directive certificate alone does not show that the transition still applies. Steps 1 to 4 below follow the evidence the Commission services list in their Q&A on Regulation (EU) 2023/607 (Q7).

1. Keep the manufacturer's self-declaration that the conditions of Article 120(3c) are met.
2. Request the optional notified-body confirmation letter on the NBCG-Med template of 26 July 2024, published by the Commission, in principle at no extra cost.
3. Keep copies of the formal application and of the signed written agreement.
4. Obtain a certificate of free sale from the competent authority where one is needed.
5. Keep the MDCG guidance and Commission documents at hand: the Q&A on Regulation (EU) 2023/607 rev.2 (July 2024) and the MDCG 2022-11 rev.1 notice to manufacturers (November 2023), neither of them legally binding.
6. Plan the MDR conformity assessment so that the MDR certificate is issued before the end date, including sufficient clinical evidence for legacy devices.

Is a Further Extension of the Deadlines Proposed?

No further extension of the 2027 and 2028 end dates is in the Commission's proposal for a targeted revision, COM(2025) 1023 of 16 December 2025 (procedure 2025/0404(COD)), which is pending; as of 6 November 2026 the European Parliament lists it as "Awaiting committee decision" in its health committee (SANT). The stage and the past procedural events are recorded in the legislative observatory file.

The proposal would let legacy orphan devices 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 also let procedures pending, and certificates issued, before 6 months after its entry into force continue under the current rules. Every adopted act and the proposal are tracked under MDR and IVDR amendments.

MDR Transition Questions

Five questions come up about the MDR transition dates.

Did the MDR transition period end on 26 May 2024?

No: 26 May 2024 was the deadline for the quality management system and the formal application, and the end dates are 31 December 2027 and 31 December 2028; without an application, the transition ended on 26 May 2024 (Commission Q&A on Regulation (EU) 2023/607, Q3).

Do legacy IVDs follow the same end dates?

No: legacy IVDs follow IVDR Article 110 as amended by Regulation (EU) 2024/1860, with 31 December 2027 for devices with an IVDD certificate and self-declared devices now in class D, 31 December 2028 for self-declared devices now in class C and 31 December 2029 for self-declared devices now in class B and sterile class A, each under the conditions of IVDR Article 110(3c). See IVDR transition periods.

Can a manufacturer still apply to use the extended transition?

No: the formal application had to be lodged by 26 May 2024 and the written agreement signed by 26 September 2024, and both dates have passed.

Can units placed on the market before an end date still be sold afterwards?

Yes: since Regulation (EU) 2023/607 deleted the sell-off date, a unit placed on the market before its end date of 31 December 2027 or 31 December 2028 may still be made available later, within its shelf life or expiry date (MDR Article 120(4)).

When did the MDR replace the two directives?

On 26 May 2021, when the MDR became applicable and the MDD and AIMDD were repealed (MDR Articles 122 and 123(2), Regulation (EU) 2020/561). The differences are compared under MDD vs MDR.