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Artifact GuideEU

EU MDR transition timeline

The main MDR transition endpoints are 26 May 2026, 31 December 2027, and 31 December 2028, but a device can use them only if it fits the stated category and continues to satisfy Article 120.

Use this chronology to identify the applicable endpoint, confirm the completed 2024 eligibility milestones, and maintain evidence through the end of transition.

Back to main artifactReview sources
Author
Sorena AI
Published
May 9, 2026
Updated
Jul 25, 2026
3 sections5 primary sources
Overview

The EU MDR transition is conditional, not an automatic extension for every device certified under the old directives. Identify the device's MDD or AIMDD basis, MDR class, certificate or declaration status, and Article 120 category. For the certificate and declaration routes in Article 120(3a) and (3b), confirm continued Directive compliance, no significant design or intended-purpose change, no unacceptable risk, the 26 May 2024 QMS and application milestones, and the 26 September 2024 . The separate Article 120(3f) route for class III custom-made implantable devices required the application and written agreement by those dates, but Article 120(3f) does not list the QMS milestone as a condition of that transition.

Section 1

Chronology and the decision at each date

Read each date together with its legal effect. The 2021 date is the MDR date of application; the 2023 amendment created the extended conditional periods; the 2024 dates were eligibility milestones; and the 2026, 2027, and 2028 dates are category-specific endpoints. They are not interchangeable launch deadlines.

The later endpoint does not revive a device that missed a condition. For Article 120(3a) and (3b) devices, the manufacturer had to put an MDR Article 10(9) QMS in place and lodge a formal conformity-assessment application with a notified body by 26 May 2024. The manufacturer and notified body then had to sign the by 26 September 2024. The class III custom-made implantable route in Article 120(3f) required the application and agreement by the same dates, but not the QMS milestone as a stated transition condition. Applications and agreements completed before Regulation (EU) 2023/607 entered into force can satisfy the relevant milestones if the application was not rejected.

  • 26 May 2021: Regulation (EU) 2017/745 became the main application date after the one-year postponement in Regulation (EU) 2020/561.
  • 20 March 2023: Regulation (EU) 2023/607 entered into force and amended the MDR transitional provisions; 15 March 2023 is the date the act was adopted.
  • 26 May 2024: manufacturers using Article 120(3a) or (3b) had to have a quality management system in place and lodge a formal application with a notified body by this date. The class III custom-made implantable route in Article 120(3f) required the formal application, but does not state the QMS milestone as a transition condition. Both branches required the by 26 September 2024.
  • 26 May 2026: class III custom-made implantable devices may be placed on the market or put into service until this date if the stated conditions are met.
  • 31 December 2027: eligible class III devices and class IIb implantable devices reach the endpoint, except sutures, staples, dental fillings, dental braces, tooth crowns, screws, wedges, plates, wires, pins, clips, and connectors.
  • 31 December 2028: eligible other class IIb devices, class IIa devices, and class I devices placed on the market in sterile condition or having a measuring function reach the endpoint.
  • 31 December 2028 also applies to eligible devices that did not require a notified body under Directive 93/42/EEC but do require one under the MDR, provided the MDD declaration of conformity was drawn up before 26 May 2021 and Article 120(3c) is satisfied.
  • No sell-off deadline: Regulation (EU) 2023/607 removed the former date after which devices lawfully placed on the market under the transition would have had to be withdrawn from the supply chain. This does not excuse non-compliance, unacceptable risk, expiry of shelf life, or a recall.
Section 2

Map the device to the correct endpoint

Start with the device as it was covered by the Directive certificate or pre-26-May-2021 declaration, then determine its MDR class. The 2027 and 2028 groups turn on that MDR class and, for class IIb devices, implantable status and the listed implantable exceptions. A product name or old MDD class is not enough to choose the endpoint.

Class III custom-made implantable devices follow a separate Article 120(3f) route to 26 May 2026. The device could be placed on the market or put into service without an Article 52(8) certificate until that date if the manufacturer lodged an MDR Annex XIII Section 2 application with a notified body by 26 May 2024 and signed the by 26 September 2024. An Article 52(8) certificate is required to continue placing the device on the market or putting it into service after 26 May 2026.

  • 2027 group: eligible class III devices and class IIb implantable devices, except the implantable items expressly assigned to the 2028 group.
  • 2028 certified-device group: eligible other class IIb devices, class IIa devices, and class I sterile or measuring devices covered by qualifying MDD or AIMDD certificates.
  • 2028 up-classified group: eligible former class I MDD devices with a declaration drawn up before 26 May 2021 that now need notified-body conformity assessment under the MDR.
  • 2026 custom-made group: class III custom-made implantable devices using Article 120(3f), not the certificate-based Article 120(3a) route.
  • No transition group: devices that do not fit a stated category, fail a continuing condition, or undergo a significant design or intended-purpose change need a different lawful market-access basis.
Section 3

Decide whether a device still qualifies for an Article 120 transition

Run this decision for each or device family; an old MDD or AIMDD certificate does not by itself preserve market access. Record the Directive basis and class, certificate or declaration status, MDR class, manufacturer and notified body, and the specific Article 120 endpoint being claimed.

Then follow the branch that applies. For Article 120(3a) and (3b), test continued Directive compliance, no in design or intended purpose, no unacceptable risk, an MDR QMS by 26 May 2024, a formal conformity-assessment application by 26 May 2024, and a written notified-body agreement by 26 September 2024. For the Article 120(3f) class III custom-made implantable route, verify the formal application and milestones separately. The continuing conditions must remain satisfied through the applicable endpoint. A failed condition means the 2027 or 2028 date cannot preserve market access and needs a documented market-access decision.

  • Qualification record: identify the exact device, Directive certificate or declaration, original and MDR class, intended purpose, configurations, certificate scope and applicable Article 120 paragraph.
  • Condition record: retain QMS implementation evidence, the notified-body application, the , certificate and surveillance-transfer evidence, competent-authority correspondence, and the current risk assessment supporting the conclusion that the device presents no unacceptable risk.
  • Change gate: screen design, intended-purpose, software, material, sterilisation, packaging and performance changes under the applicable legal text and MDCG 2020-3 guidance; guidance supports the analysis but is not the binding rule.
  • Lifecycle duties: continue MDR PMS, market-surveillance, vigilance, and economic-operator registration duties that apply during transition; do not treat legacy status as a freeze on post-market obligations.
  • Endpoint control: use 26 May 2026, 31 December 2027 or 31 December 2028 only after mapping the device to the correct class/category and confirming every continuing condition.
Recommended next step

Document the transition endpoint for each device

Record the Article 120 category, continuing conditions, certificate path, application and agreement evidence, significant-change decisions, surveillance owner, and next MDR conformity-assessment milestone.

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Primary sources

References and citations

Regulation (EU) 2017/745 on medical devices
eur-lex.europa.eu3 citations
Referenced sections
  • Binding MDR source for the date of application, Article 120 transition structure, device classification, and continuing lifecycle duties.
  • Binding source for MDR classification and the Article 120 transition categories, including the separate custom-made class III implantable route.
  • Binding MDR source for Article 120 transition structure and the PMS, market-surveillance, vigilance and registration duties that apply to legacy devices during transition.
Regulation (EU) 2023/607 on MDR and IVDR transitional provisions
eur-lex.europa.eu3 citations
Referenced sections
  • Binding amendment source for MDR transition conditions and legacy-device timing.
  • Binding amendment source for the 2026, 2027, and 2028 endpoints and the devices assigned to each group.
  • Binding amendment source for the conditional 2026, 2027 and 2028 endpoints and the QMS, application, agreement, risk and no-significant-change conditions.
European Commission Q&A on Regulation (EU) 2023/607
health.ec.europa.eu2 citations
Referenced sections
  • Official explanatory guidance for eligible devices, application and agreement evidence, QMS scope, and practical use of the amended transition.
  • Commission explanatory guidance on eligible legacy devices, pre-existing applications and agreements, formal application content, and evidence of transition status.

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