TransitionEU

EU Medical Device Regulation (MDR) 2017/745 Transition Timelines

Legacy device transition is conditional - plan like it's a gated program.

This guide focuses on Article 120 conditions, significant-change control, written-agreement and surveillance transfer mechanics, and the practical legacy-device evidence pack.

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Author
Sorena AI
Published
Feb 22, 2026
Updated
Feb 22, 2026
Sections
3

Structured answer sets in this page tree.

Primary sources
4

Cited legal and guidance references.

Publication metadata
Sorena AI
Published Feb 22, 2026
Updated Feb 22, 2026
Overview

Transition timelines are not just dates - they are conditions. The most common failure mode is assuming a transitional extension applies automatically. In practice, you need evidence that your device qualifies, that you met specific cut-offs (for notified body engagement where applicable), and that you avoided disqualifying changes. Use this page to turn transition rules into a timeline you can execute.

Section 1

Build a legacy-device transition dossier (the file you need when asked why the device is still moving under transition)

If you rely on transition, keep one dossier that proves the device still qualifies. The core question is not whether the date exists. The core question is whether the Article 120 conditions still hold today.

Control: version the dossier and require an update every time scope, design, intended purpose, notified-body status, or QMS status changes.

  • Certificate history and lawful placing-on-the-market evidence, including whether the device was already lawfully marketed before 22 June 2023 where that condition matters.
  • Directive-compliance evidence plus the statement that MDR post-market surveillance, vigilance, market-surveillance, and registration rules now replace the corresponding directive rules for legacy devices.
  • Significant-change assessments tied to design and intended-purpose changes, with cross-links to CER, risk management, labeling, and software-release records.
  • Article 10(9) QMS evidence, PRRC coverage, PMS and vigilance procedures, and proof that the QMS was in place by 26 May 2024 where Article 120(3c)(d) applied.
  • Formal application evidence, written agreement, and surveillance-transfer records for the notified body that became responsible by 26 September 2024.
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Section 2

Key transition cutoffs to calendar (focus on conditions, not just dates)

Transition is conditional. Strong technical documentation does not rescue a missed legal condition, and a calendar without evidence fields is not enough.

Control: every transition milestone should link to the specific document set that proves the condition was met and remains met.

  • 20 March 2023: applications lodged before this date remain valid for Article 120(3c)(e) if they were not rejected, so do not duplicate paperwork without checking the existing file first.
  • 26 May 2024: the manufacturer or authorised representative needed to lodge the formal conformity-assessment application by this date where Article 120(3c)(e) applied, and the manufacturer needed the MDR QMS in place by this date under Article 120(3c)(d).
  • 26 September 2024: the written agreement under Annex VII section 4.3 had to be signed by this date, and the MDR notified body that signed it became responsible for the appropriate surveillance at the latest by then.
  • 31 December 2027 or 31 December 2028: the applicable end date depends on MDR Annex VIII classification logic, while some ongoing obligations such as PSUR may still use directive-era class logic for legacy devices.
  • 26 May 2026: class III custom-made implantable devices lose the special transition route after this date unless the device has already moved onto the full MDR conformity path.
Section 3

Significant changes during transition (make it a controlled decision)

Significant changes can break transition eligibility. The practical answer is not to freeze the device forever. The practical answer is to make every design and intended-purpose change pass through a documented Article 120 review.

Control: require a significant-change assessment before approving design changes, intended-purpose edits, claim changes, major supplier changes, or software releases.

  • Use MDCG 2020-3 Rev.1 as the baseline for deciding whether the change is significant, and keep the rationale inside the design-change record rather than in email threads.
  • Check software carefully. New data inputs, model retraining, new clinical outputs, automation changes, and changed user populations can all affect intended purpose or risk and force a deeper review.
  • Keep the evidence chain aligned: classification memo, CER, risk file, GSPR checklist, IFU, PMS plan, and UDI records should all reflect the same change decision.
  • If the manufacturer withdraws the application or the written agreement is terminated without a valid transfer to another notified body, the transition condition in Article 120(3c)(e) is no longer met.
  • If you transfer to another notified body, update the legacy-device transition dossier immediately so the new surveillance and agreement trail is complete.
Primary sources

References and citations

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