See how long your legacy device can stay on the EU market, in a few clicks.
- Your end dateDecember 31, 2027 or 2028 for your device class, and how many days are left.
- Every condition checkedQuality system, notified body dates and design changes, each marked yes, no or to check.
- Next steps and referencesWhat to do now, with the MDR article or Commission Q&A behind each rule.
The short answer
Under the EU Medical Device Regulation (MDR), a legacy device, one certified or declared under the old directives (MDD, AIMDD) before May 26, 2021, can be placed on the market until December 31, 2027 (Class III and most Class IIb implants with a certificate) or December 31, 2028 (other devices that need certification by a notified body under the MDR). The date holds only if you had an MDR quality management system and a notified body application by May 26, 2024, a signed agreement by September 26, 2024, and make no significant change.
How it works
- Answer a few questionsGive the class under the MDR rules (Annex VIII), which can differ from the class on your MDD certificate, and say what covered the device before May 26, 2021.
- We apply Article 120The tool follows Article 120 of the MDR (Regulation (EU) 2017/745) as amended by Regulation (EU) 2023/607, checked on October 22, 2026, and not the Commission’s 2025 proposal.
- You get your end dateIt comes with each condition and your answer to it, and the next steps for your case.
The old certificate must have been valid on May 26, 2021 and not withdrawn. Until the end date, the device must keep complying with the MDD or AIMDD and pose no unacceptable risk to health or safety. If a condition fails, the device loses the transition and new units can be placed on the market only under the MDR, although moving the application to another notified body under a new agreement at the same time does not end it.
EU MDR transition deadlines by device class
| Legacy device (class under the MDR) | Covered before May 26, 2021 by | May be placed on the market until | Article |
|---|---|---|---|
| Class III | MDD or AIMDD certificate | December 31, 2027 | 120(3a)(a) |
| Class IIb implantable | MDD or AIMDD certificate | December 31, 2027 | 120(3a)(a) |
| Class IIb implantable sutures, staples, dental fillings, dental braces, tooth crowns, screws, wedges, plates, wires, pins, clips and connectors | MDD or AIMDD certificate | December 31, 2028 | 120(3a)(b) |
| Class IIb, not implantable | MDD or AIMDD certificate | December 31, 2028 | 120(3a)(b) |
| Class IIa | MDD or AIMDD certificate | December 31, 2028 | 120(3a)(b) |
| Class I placed on the market sterile or with a measuring function | MDD or AIMDD certificate | December 31, 2028 | 120(3a)(b) |
| MDD Class I without a notified body that needs one under the MDR, for example a reusable surgical instrument | EC declaration of conformity | December 31, 2028 | 120(3b) |
| Class III custom-made implantable | Application by May 26, 2024, written agreement by September 26, 2024 | May 26, 2026 (ended) | 120(3f) |
| Class I with no notified body under the MDR | EC declaration of conformity | No transitional period: must meet the MDR | 120(3b) |
The check leaves out in vitro diagnostic devices, which have their own transitional periods under Article 110 of the IVDR (Regulation (EU) 2017/746), and custom-made devices other than Class III implantable ones, which are placed on the market with the statement under Annex XIII of the MDR. National measures under Articles 59 and 97 beyond its date test, and rules in markets outside the EU, are not covered either. The engineering behind MDR certification, such as redesigns, replacements for obsolete components and test evidence, is outside it too; our cost calculator estimates that work by phase.
What OVA does here, and where our responsibility ends
We design the electronics, firmware and mechanics of medical devices and take them from concept to design for manufacturing. We are not a regulatory consultancy and not a contract manufacturer: the regulatory strategy and the submission stay with you or your regulatory consultant.
The result is an orientation, not a regulatory opinion. OVA Solutions is not a notified body: confirm the end date and the conditions with your notified body. The tool runs in your browser. Your answers are not sent to us; with your cookie consent, Google Analytics records only that the tool was used and the category of the result.
Questions
Can I still sell MDD devices after 2027 or 2028?
Yes, for units placed on the market by the end date: they can still be made available and put into service, with no time limit other than their own shelf life or expiry date. Regulation (EU) 2023/607 deleted the sell-off date that used to stop such units one year after the end of the transitional period. Any new unit after the end date needs an MDR certificate.
My MDD certificate has expired. Is it still valid?
Yes, if it was issued from May 25, 2017, was valid on May 26, 2021 and on March 20, 2023, and has not been withdrawn: the law extended it to the end date for the device class while the conditions hold. If it expired before March 20, 2023, it counts only with a written agreement with a notified body signed before the expiry, or a national derogation or required conformity assessment before March 20, 2023.
Do I need a new certificate or letter to prove the extension?
No, the extension applies by law once the conditions are met. The Commission says you should be able to provide a self-declaration that they are fulfilled, stating the end date. A confirmation letter from your notified body is optional extra evidence.
What counts as a significant change?
The guidance is MDCG 2020-3 Rev.1 from the EU’s Medical Device Coordination Group, and it is worth confirming with your notified body before you change the device. Administrative changes, such as a new company name, address or legal form, are generally not changes in design or intended purpose. A replacement device needs the full MDR conformity assessment first; once it is certified, it can be on the market in parallel with the legacy device until the legacy end date.
Will the EU extend the MDR deadlines again?
No further extension has been adopted. The Commission’s proposal of December 16, 2025 (COM(2025) 1023) keeps the 2027 and 2028 dates and would let legacy orphan devices, the ones for small patient groups, stay on the market after them with an expert panel opinion. As of October 22, 2026 the proposal was awaiting a committee decision in the European Parliament, with an indicative plenary date of December 14, 2026.
Related pages
Sources
- Regulation (EU) 2023/607 of March 15, 2023 amending the MDR and the IVDR transitional provisions, OJ L 80, March 20, 2023
- Regulation (EU) 2017/745 (MDR), consolidated text of July 19, 2026: Articles 5, 52, 120 and 123
- Regulation (EU) 2024/1860 of June 13, 2024 (Article 10a, interruption or discontinuation of supply), OJ July 9, 2024
- Directive 93/42/EEC (MDD), consolidated text of October 11, 2007: Article 11(5) and Annex VII
- European Commission: Q&A on practical aspects related to the implementation of Regulation (EU) 2023/607, Rev. 2, July 2024
- European Commission: EUDAMED overview and transition timeline, accessed October 22, 2026
- European Commission: proposal COM(2025) 1023 of December 16, 2025 amending the MDR and the IVDR
- European Parliament Legislative Observatory: procedure 2025/0404(COD), accessed October 22, 2026
Data as of October 22, 2026. By Lisa Voronkova, CEO of OVA Solutions. Updated on October 22, 2026.