--- title: "Transition Timelines" canonical_url: "https://www.sorena.io/artifacts/eu/medical-device-regulation/transition-timelines" source_url: "https://www.sorena.io/artifacts/eu/medical-device-regulation/transition-timelines" author: "Sorena AI" description: "A practical MDR transition and legacy-device timeline guide: how Article 120 works after Regulation (EU) 2023/607, which conditions must stay true." published_at: "2026-02-22" updated_at: "2026-02-22" keywords: - "EU MDR transition timelines" - "MDR transitional provisions" - "legacy devices MDR" - "Regulation (EU) 2023/607 MDR" - "MDR transition extension 2027 2028" - "notified body application deadline 26 May 2024" - "notified body agreement deadline 26 September 2024" - "significant changes MDR Article 120 MDCG 2020-3" - "sell-off period removed MDR" - "EU MDR" - "Transition Timelines" - "Legacy devices" - "2023/607" - "Significant changes" --- **[SORENA](https://www.sorena.io/)** - AI-Powered GRC Platform [Home](https://www.sorena.io/) | [Solutions](https://www.sorena.io/solutions) | [Artifacts](https://www.sorena.io/artifacts) | [About Us](https://www.sorena.io/about-us) | [Contact](https://www.sorena.io/contact) | [Portal](https://app.sorena.io) --- # Transition Timelines A practical MDR transition and legacy-device timeline guide: how Article 120 works after Regulation (EU) 2023/607, which conditions must stay true. *Transition* *EU* ## 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. 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. ## 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. *Recommended next step* *Placement: after the timeline or milestone section* ## Turn EU Medical Device Regulation (MDR) 2017/745 Transition Timelines into an operational assessment Assessment Autopilot can take EU Medical Device Regulation (MDR) 2017/745 Transition Timelines from planning deadlines, owners, and milestones from this page to a reusable workflow inside Sorena. Teams working on EU Medical Device Regulation (MDR) 2017/745 can keep owners, evidence, and next steps aligned without copying this guide into separate documents. - [Open Assessment Autopilot for EU Medical Device Regulation (MDR) 2017/745 Transition Timelines](/solutions/assessment.md): Start from EU Medical Device Regulation (MDR) 2017/745 Transition Timelines and turn the guidance into owned tasks, evidence requests, and review checkpoints. - [Talk through EU Medical Device Regulation (MDR) 2017/745](/contact.md): Review your current process, evidence gaps, and next steps for EU Medical Device Regulation (MDR) 2017/745 Transition Timelines. ## 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. ## 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 - [Regulation (EU) 2017/745 - Medical Device Regulation (MDR) (EUR-Lex)](https://eur-lex.europa.eu/eli/reg/2017/745/oj/eng?ref=sorena.io) - Primary legal text for Article 120, Article 10(9), and legacy-device obligations. - [Regulation (EU) 2023/607 (EUR-Lex)](https://eur-lex.europa.eu/eli/reg/2023/607/oj/eng?ref=sorena.io) - Amending regulation that extended the transitional period and removed the sell-off deadline. - [Q&A rev.2 on Regulation (EU) 2023/607 (European Commission)](https://health.ec.europa.eu/document/download/592008f6-3456-4afb-a13a-733a87da1b00_en?filename=mdr_proposal_extension-q-n-a_1.pdf&ref=sorena.io) - Official Commission Q and A clarifying the 2024 application and written-agreement deadlines, QMS timing, class III custom-made implantable timing, and transfer between notified bodies. - [MDCG 2020-3 Rev.1 - Significant changes under MDR Article 120 (European Commission)](https://health.ec.europa.eu/document/download/800e8e87-d4eb-4cc5-b5ad-07a9146d7c90_en?filename=mdcg_2020-3_en_1.pdf&ref=sorena.io) - Operational guidance for deciding whether a design or intended-purpose change breaks transition eligibility. ## Related Topic Guides - [Applicability Test | EU Medical Device Regulation (MDR) 2017/745 | Is it a Medical Device? Annex XVI? Software Rule 11?](/artifacts/eu/medical-device-regulation/applicability-test.md): A step-by-step MDR applicability test for Regulation (EU) 2017/745: confirm intended purpose, device definition and exclusions. - [CER Template | EU Medical Device Regulation (MDR) 2017/745 | Clinical Evaluation Report Structure (Annex XIV)](/artifacts/eu/medical-device-regulation/clinical-evaluation-report-template.md): A practical Clinical Evaluation Report (CER) template for MDR (Regulation (EU) 2017/745): a copy-ready CER structure aligned to Annex XIV. - [Clinical Evaluation Overview | EU Medical Device Regulation (MDR) 2017/745 | CER, Clinical Evidence Strategy, PMCF](/artifacts/eu/medical-device-regulation/clinical-evaluation-overview.md): A practical MDR clinical evaluation overview: how to define clinical claims and intended purpose, plan the clinical evaluation (CEP). - [Compliance Checklist | EU Medical Device Regulation (MDR) 2017/745 | Technical Documentation, Clinical Evaluation, PMS, UDI/EUDAMED](/artifacts/eu/medical-device-regulation/checklist.md): An MDR compliance checklist you can run per device family: scope + role, classification and conformity assessment route, QMS controls (incl. - [Compliance Guide | EU Medical Device Regulation (MDR) 2017/745 | QMS, Technical Documentation, Clinical Evaluation, PMS, UDI/EUDAMED](/artifacts/eu/medical-device-regulation/compliance.md): A practical EU MDR compliance guide for Regulation (EU) 2017/745: how to build an MDR operating model from scope and classification to conformity assessment. - [Deadlines and Compliance Calendar | EU Medical Device Regulation (MDR) 2017/745 | Transition, Legacy Devices, EUDAMED](/artifacts/eu/medical-device-regulation/deadlines-and-compliance-calendar.md): A practical MDR deadlines and compliance calendar: MDR application timing, Regulation (EU) 2023/607 transition conditions. - [Device Classification Guide | EU Medical Device Regulation (MDR) 2017/745 | Annex VIII + Software Rule 11](/artifacts/eu/medical-device-regulation/device-classification-guide.md): A practical MDR device classification guide for Annex VIII: how to write a classification memo, apply implementing rules, decide invasiveness and duration. - [FAQ | EU Medical Device Regulation (MDR) 2017/745 | Scope, Classification, Technical File, Clinical Evaluation, UDI/EUDAMED](/artifacts/eu/medical-device-regulation/faq.md): High-signal EU MDR FAQ: Is my product a medical device? Is my software in scope? What is Rule 11? Do I need a notified body? What goes in the technical file. - [MDR vs IVDR | EU Medical Device Regulation (MDR) 2017/745 vs IVDR 2017/746 | Classification, Evidence, UDI/EUDAMED](/artifacts/eu/medical-device-regulation/mdr-vs-ivdr.md): A practical MDR vs IVDR comparison for mixed device portfolios: scope differences (medical devices vs in vitro diagnostics), classification approaches. - [Penalties and Fines | EU Medical Device Regulation (MDR) 2017/745 | Enforcement Risk + How to Reduce Exposure](/artifacts/eu/medical-device-regulation/penalties-and-fines.md): A practical MDR enforcement guide: how penalties work under EU MDR (sanctions set by Member States), common enforcement triggers (misleading claims. - [PMS and Vigilance | EU Medical Device Regulation (MDR) 2017/745 | PMS Plan, PSUR, Serious Incidents, FSCA](/artifacts/eu/medical-device-regulation/post-market-surveillance-and-vigilance.md): A practical MDR PMS and vigilance guide: build the Annex III PMS system, decide when PSUR or PMS report applies, meet serious-incident timelines of 15 days. - [PMS Plan Template | EU Medical Device Regulation (MDR) 2017/745 | Annex III-Aligned Outline + Metrics](/artifacts/eu/medical-device-regulation/post-market-surveillance-plan-template.md): A practical MDR Post-Market Surveillance (PMS) plan template aligned to MDR Annex III: copy-ready sections for device scope, data sources. - [QMS and Technical File | EU Medical Device Regulation (MDR) 2017/745 | Annex II/III Technical Documentation + QMS Controls](/artifacts/eu/medical-device-regulation/qms-and-technical-file.md): A practical MDR QMS and technical-file guide: Article 10 and 15 governance, Annex II and III file structure, GSPR traceability. - [Requirements | EU Medical Device Regulation (MDR) 2017/745 | Core Obligations + Evidence Outputs](/artifacts/eu/medical-device-regulation/requirements.md): A grounded MDR requirements guide for Regulation (EU) 2017/745: scope and role mapping, Annex VIII classification, Article 10 and 15 governance. - [UDI and EUDAMED | EU Medical Device Regulation (MDR) 2017/745 | UDI-DI/PI, Basic UDI-DI, Actor Registration, Device Registration](/artifacts/eu/medical-device-regulation/udi-and-eudamed.md): A practical MDR UDI and EUDAMED guide: Basic UDI-DI, UDI-DI, UDI-PI, actor registration and SRN, Article 29 device registration. --- [Privacy Policy](https://www.sorena.io/privacy) | [Terms of Use](https://www.sorena.io/terms-of-use) | [DMCA](https://www.sorena.io/dmca) | [About Us](https://www.sorena.io/about-us) (c) 2026 Sorena AB (559573-7338). 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