--- title: "EU MDR deadlines and compliance calendar" canonical_url: "https://www.sorena.io/artifacts/eu/medical-device-regulation/deadlines-and-compliance-calendar" source_url: "https://www.sorena.io/artifacts/eu/medical-device-regulation/deadlines-and-compliance-calendar" author: "Sorena AI" description: "Official source EU MDR calendar for application, legacy-device transition, UDI, EUDAMED, and recurring QMS, technical documentation, clinical, PMS, vigilance, certificate, and change reviews." published_at: "2026-05-09" updated_at: "2026-05-26" keywords: - "EU MDR deadlines" - "MDR transition dates" - "Regulation (EU) 2017/745" - "MDR legacy devices" - "UDI deadlines" - "EUDAMED mandatory modules" - "EU Medical Device Regulation" - "EU MDR" - "EUDAMED" --- **[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) --- # EU MDR deadlines and compliance calendar Official source EU MDR calendar for application, legacy-device transition, UDI, EUDAMED, and recurring QMS, technical documentation, clinical, PMS, vigilance, certificate, and change reviews. *Compliance Calendar* *EU MDR* ## EU MDR deadlines and compliance calendar A cited calendar for MDR application, legacy-device transition dates, UDI carrier timing, EUDAMED module timing, and recurring operational reviews. Use it to separate fixed legal dates from ongoing review events for QMS, technical documentation, clinical evaluation, PMS, vigilance, certificates, and design or intended-purpose changes. This EU MDR calendar focuses on cited dates and repeatable compliance review events. It does not add national filing dates, invented submission windows, or generic project-management milestones. Timings on this page are tied to cited sources; verify current legal source language before implementation decisions. ## Fixed MDR transition and application dates Use these dates as the backbone of an MDR calendar. For each device family, record the applicable risk class, certificate basis, notified-body status, whether the legacy conditions are still met, and the owner responsible for keeping evidence current. Legacy-device transition dates are conditional. Regulation (EU) 2023/607 ties the extended placement or putting-into-service windows to continued Directive compliance, no significant design or intended-purpose change, no unacceptable public-health risk, QMS implementation by 26 May 2024, a notified-body application by 26 May 2024, and a written notified-body agreement by 26 September 2024. - 26 May 2021: MDR date of application for medical devices after the COVID-era one-year postponement. - 26 May 2024: deadline, for eligible legacy devices relying on Article 120 transition, to have a QMS in place and lodge the formal MDR conformity-assessment application with a notified body. - 26 September 2024: deadline for the notified body and manufacturer to sign the written agreement for eligible legacy devices relying on the extended transition. - 26 May 2026: transition endpoint for class III custom-made implantable devices without a notified-body certificate, where the Article 120(3f) conditions are met. - 31 December 2027: transition endpoint for eligible class III devices and class IIb implantable devices, except the listed lower-risk implantable items. - 31 December 2028: transition endpoint for eligible other class IIb devices, class IIa devices, class I sterile or measuring devices, and certain devices newly requiring notified-body involvement under the MDR. Sources for this answer: - [Regulation (EU) 2023/607 on MDR transitional provisions](https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A32023R0607&ref=sorena.io) - Grounds the 26 May 2024, 26 September 2024, 26 May 2026, 31 December 2027, and 31 December 2028 transition conditions and endpoints. - [Regulation (EU) 2020/561 postponing MDR application](https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A32020R0561&ref=sorena.io) - Grounds the one-year postponement that moved MDR application for medical devices to 26 May 2021. *Recommended next step* *Placement: after calendar section* ## Check your MDR calendar against device evidence Review transition eligibility, UDI status, EUDAMED readiness, certificate dependencies, and recurring QMS, clinical, PMS, vigilance, and change-control reviews for each device family. - [Open Research Copilot](/solutions/research-copilot.md): Answer MDR timing and transition questions with cited outputs. - [Talk through implementation](/contact.md): Review your device calendar, source evidence, and operating controls. ## UDI and EUDAMED calendar entries Track UDI and EUDAMED separately from the legacy-device transition. UDI assignment, UDI carrier placement, direct marking, database readiness, and EUDAMED account access can have different owners and review evidence. For UDI data, the operating control should include a change trigger: where a device data element changes but a new UDI-DI is not required, the MDR UDI database rule requires the relevant record to be updated within 30 days. - 26 May 2021: UDI assignment obligation applies for medical devices. - 26 May 2021: UDI carrier placement deadline for implantable devices and class III devices. - 26 May 2023: UDI carrier placement deadline for class IIa and class IIb devices; direct marking deadline for reusable implantable and class III devices. - 26 May 2025: UDI carrier placement deadline for class I devices; direct marking deadline for reusable class IIa and class IIb devices. - 26 May 2027: direct marking deadline for reusable class I devices. - 28 May 2026: mandatory use starts for the first four EUDAMED modules: Actor, UDI/devices, notified bodies and certificates, and market surveillance. Sources for this answer: - [EUDAMED portal](https://webgate.ec.europa.eu/eudamed?ref=sorena.io) - Grounds the six EUDAMED module categories and mandatory use of the first four modules from 28 May 2026. - [Regulation (EU) 2017/745 on medical devices](https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32017R0745&locale=en&ref=sorena.io) - Grounds UDI carrier timing by device class, reusable-device direct marking, and UDI database maintenance including 30-day updates where no new UDI-DI is required. ## Recurring operational reviews to put on the calendar Not every MDR calendar entry is a fixed filing deadline. Many controls are ongoing obligations that should be scheduled as review events with a trigger, evidence owner, and output record. Set the cadence by device risk, certificate commitments, PMS plan, PMCF plan, notified-body agreement, and change-control procedure. Avoid publishing a date unless the source or the approved quality record actually sets one. - QMS review: confirm procedures remain implemented, maintained, kept up to date, and continually improved; include design changes, standard or common-specification changes, supplier changes, PMS outputs, vigilance signals, and corrective actions. - Technical documentation review: verify Annex II and Annex III files remain up to date, including device description, specifications, risk management, verification and validation, PMS plan, PMCF plan, and links to certificates or declarations. - Clinical evaluation review: update the clinical evaluation plan, literature review, clinical data appraisal, clinical evaluation report, PMCF findings, and benefit-risk conclusions when PMS or PMCF evidence changes. - PMS and vigilance review: review post-production experience, complaints, incidents, field safety corrective actions, PMCF outputs, and preventive or corrective actions; serious incidents and field safety corrective actions must be reported as soon as the manufacturer learns of them. - Certificate and notified-body review: track certificate expiry or validity, surveillance responsibility, written agreements, scope changes, restrictions, and whether transition conditions continue to be satisfied. - Change review: screen every design, intended-purpose, label, packaging, UDI data, critical warning, contraindication, sterility, model, or trade-name change before release, because some changes can end transition eligibility or require a new UDI-DI. Sources for this answer: - [Regulation (EU) 2017/745 on medical devices](https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32017R0745&locale=en&ref=sorena.io) - Grounds ongoing QMS, technical documentation, PMS, vigilance, UDI database, clinical evaluation, and PMCF review obligations. - [Regulation (EU) 2023/607 on MDR transitional provisions](https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A32023R0607&ref=sorena.io) - Grounds the need to monitor legacy-device transition conditions, significant changes, notified-body agreements, and surveillance transfer. ## Primary sources - [Regulation (EU) 2017/745 on medical devices](https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32017R0745&locale=en&ref=sorena.io) - Primary MDR source for QMS, technical documentation, clinical evaluation, PMS, vigilance, UDI database maintenance, and ongoing manufacturer controls. - Quote: "draw up and keep up to date technical documentation" - [Regulation (EU) 2020/561 postponing MDR application](https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A32020R0561&ref=sorena.io) - Grounds the postponement of the MDR date of application to 26 May 2021. - Quote: "the date of application of Regulation (EU) 2017/745 should be deferred" - [Regulation (EU) 2023/607 on MDR transitional provisions](https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A32023R0607&ref=sorena.io) - Grounds the extended MDR transition dates, transition conditions, legacy-device PMS and vigilance obligations, and notified-body written-agreement milestone. - Quote: "transitional provisions for certain medical devices" - [EUDAMED portal](https://webgate.ec.europa.eu/eudamed?ref=sorena.io) - Grounds EUDAMED module categories and mandatory use of the first four modules from 28 May 2026. - Quote: "mandatory to use the first four modules" ## Related Topic Guides - [Custom-made medical devices under the EU MDR | EU MDR FAQ](/artifacts/eu/medical-device-regulation/faq/custom-made-devices.md): Concise EU MDR FAQ on custom-made device definition, mass-produced exclusions, Annex XIII statements, documentation, conformity assessment, PMS, vigilance, and records to retain. - [EU MDR Annex II and III Technical Documentation](/artifacts/eu/medical-device-regulation/annex-ii-and-iii-technical-documents.md): Build an MDR technical documentation index for Annex II device files and Annex III post-market surveillance evidence, including GSPR, risk, clinical, PMS, UDI, and EUDAMED records. - [EU MDR Annex VIII Classification Guide](/artifacts/eu/medical-device-regulation/annex-viii-classification.md): Classify EU MDR medical devices under Annex VIII using intended purpose, duration, invasiveness, active device and software rules, and conformity assessment impact. - [EU MDR Annex XVI products without a medical purpose](/artifacts/eu/medical-device-regulation/annex-xvi-products.md): cited EU MDR guide for Annex XVI products: listed product groups, common specifications, clinical evidence, notified-body route, UDI, EUDAMED, PMS, and vigilance evidence before launch. - [EU MDR Applicability Test](/artifacts/eu/medical-device-regulation/applicability-test.md): Test whether a product, accessory, software function, or Annex XVI product falls under the EU Medical Device Regulation, and record the evidence for the next classification step. - [EU MDR change assessment workflow](/artifacts/eu/medical-device-regulation/change-assessment-workflow.md): Assess EU MDR device, design, software, intended purpose, QMS, clinical, PMS, UDI, classification, and notified-body impacts before releasing a medical device change. - [EU MDR Checklist for Medical Device Compliance](/artifacts/eu/medical-device-regulation/checklist.md): Practical EU MDR checklist covering qualification, classification, conformity assessment, technical documentation, GSPR, clinical evidence, UDI, EUDAMED, PMS, vigilance, QMS, and legacy transition evidence. - [EU MDR classification workflow](/artifacts/eu/medical-device-regulation/classification-workflow.md): A concrete EU MDR classification workflow for intended purpose, device or accessory qualification, Annex VIII rule selection, Rule 11 software review, class outcome, and notified body impact. - [EU MDR Clinical Evaluation Overview](/artifacts/eu/medical-device-regulation/clinical-evaluation-overview.md): EU MDR clinical evaluation overview covering Article 61, Annex XIV, clinical data sources, equivalence, PMCF, CER evidence, notified body review, GSPR, and benefit-risk support. - [EU MDR Clinical Evaluation Report Template](/artifacts/eu/medical-device-regulation/clinical-evaluation-report-template.md): A cited EU MDR clinical evaluation report template covering intended purpose, GSPR linkage, clinical data appraisal, equivalence limits, PMCF, conclusions, and reviewer signoff. - [EU MDR clinical evidence guide](/artifacts/eu/medical-device-regulation/clinical-evidence.md): cited EU MDR guide to clinical evaluation, clinical investigations, equivalence, PMCF, GSPR support, technical documentation, and notified-body review. - [EU MDR compliance obligations](/artifacts/eu/medical-device-regulation/compliance.md): EU MDR compliance guide for device qualification, classification, conformity assessment, QMS, technical documentation, UDI, EUDAMED, PMS, vigilance, and legacy transition controls. - [EU MDR conformity route workflow](/artifacts/eu/medical-device-regulation/conformity-route-workflow.md): cited EU MDR workflow for classifying a device, choosing the conformity assessment route, preparing technical and QMS evidence, and reaching certificate, DoC, UDI, EUDAMED, and CE outputs. - [EU MDR Device Classification Guide](/artifacts/eu/medical-device-regulation/device-classification-guide.md): Classify an EU MDR medical device by intended purpose, Annex VIII duration, invasiveness, active-device and software rules, then document the conformity route impact. - [EU MDR EUDAMED and UDI registration](/artifacts/eu/medical-device-regulation/eudamed-and-udi.md): cited MDR guide to Basic UDI-DI, UDI-DI, EUDAMED device registration, actor roles, labels, technical documentation, and UDI data governance. - [EU MDR FAQ: qualification, evidence, UDI, and transition](/artifacts/eu/medical-device-regulation/faq.md): Concise EU MDR FAQ covering device qualification, software classification, accessories, custom-made devices, clinical evidence, UDI, EUDAMED, notified bodies, significant changes, and legacy transition. - [EU MDR Legacy Device Transition](/artifacts/eu/medical-device-regulation/legacy-device-transition.md): cited EU MDR legacy device transition guide covering Regulation (EU) 2023/607 conditions, certificate validity, significant-change limits, surveillance, PMS, vigilance, QMS, and evidence records. - [EU MDR notified body route selection](/artifacts/eu/medical-device-regulation/notified-body-route-selection.md): Choose an EU MDR conformity assessment route by device class, Article 52 option, notified body designation scope, QMS readiness, technical documentation, clinical evidence, and certificate evidence. - [EU MDR penalties and enforcement risk](/artifacts/eu/medical-device-regulation/penalties-and-fines.md): cited EU MDR penalties and enforcement-risk guide covering Article 113, Member State penalty rules, market restrictions, recalls, certificate consequences, and evidence. - [EU MDR PMS and Vigilance Guide](/artifacts/eu/medical-device-regulation/pms-and-vigilance.md): EU MDR guide to post-market surveillance, PMCF updates, PMS reports, PSURs, serious incident reporting, FSCA/FSN handling, trend reporting, and evidence records. - [EU MDR PMS and vigilance records](/artifacts/eu/medical-device-regulation/post-market-surveillance-and-vigilance.md): cited EU MDR guide to PMS plans, PMS reports, PSURs, PMCF updates, serious incident and FSCA reporting, trend reporting, and EUDAMED evidence handling. - [EU MDR PMS Plan Template for Medical Devices](/artifacts/eu/medical-device-regulation/post-market-surveillance-plan-template.md): A cited EU MDR post-market surveillance plan template covering device scope, PMS data sources, PMCF linkage, vigilance, trend reporting, PMSR or PSUR outputs, roles, cadence, and evidence records. - [EU MDR QMS and technical file evidence map](/artifacts/eu/medical-device-regulation/qms-and-technical-file.md): Map EU MDR Article 10 QMS duties to Annex II and Annex III technical documentation, PMS, vigilance, UDI records, and notified-body review evidence. - [EU MDR QMS requirements under Article 10](/artifacts/eu/medical-device-regulation/qms.md): EU MDR QMS guide for Article 10 manufacturer controls covering regulatory strategy, design, risk, clinical evaluation, PMS, vigilance, UDI, suppliers, CAPA, and conformity records. - [EU MDR qualification and borderline products](/artifacts/eu/medical-device-regulation/qualification-and-borderline-products.md): EU MDR qualification guide for medical purpose claims, accessories, software, Annex XVI products, and borderline routes to classification and conformity assessment. - [EU MDR qualification workflow](/artifacts/eu/medical-device-regulation/qualification-workflow.md): A concrete EU MDR workflow for deciding whether a product is a medical device, accessory, Annex XVI product, IVD interface, medicinal-product interface, or non-MDR product before classification and conformity assessment. - [EU MDR requirements checklist](/artifacts/eu/medical-device-regulation/requirements.md): Concrete EU MDR requirements for medical-device scope, classification, GSPR, conformity assessment, technical documentation, QMS, clinical evidence, UDI, EUDAMED, PMS, vigilance, and economic-operator records. - [EU MDR Rule 11 software classification](/artifacts/eu/medical-device-regulation/rule-11-software.md): Classify MDR medical device software under Rule 11 using intended purpose, diagnosis or therapy decision impact, physiological monitoring, conformity route, clinical evidence, and software-change records. - [EU MDR significant changes FAQ: legacy-device transition and notified-body review](/artifacts/eu/medical-device-regulation/faq/significant-changes.md): FAQ on MDR significant changes for legacy devices, including intended-purpose, design, software, material, sterilisation, clinical, QMS, notified-body, and evidence impacts. - [EU MDR Transition Timelines: practical guide](/artifacts/eu/medical-device-regulation/transition-timelines.md): EU Medical Device Regulation guide to Transition Timelines with scope decisions, owner actions, evidence records, cited citations, and practical next steps. - [EU MDR UDI and EUDAMED registration guide](/artifacts/eu/medical-device-regulation/udi-and-eudamed.md): EU MDR guide to Basic UDI-DI, UDI-DI, UDI carriers, EUDAMED actor and device registration, change impacts, and evidence governance. - [EU MDR vigilance reporting workflow](/artifacts/eu/medical-device-regulation/vigilance-reporting-workflow.md): Concrete EU MDR vigilance workflow for incident intake, serious incident assessment, FSCA and FSN handling, trend reporting, EUDAMED caveats, CAPA, PMS, clinical evaluation updates, and records. - [How should Basic UDI-DI and UDI-DI be assigned under the EU MDR? | EU MDR FAQ](/artifacts/eu/medical-device-regulation/faq/udi-di-and-basic-udi-di.md): EU MDR FAQ explaining what Basic UDI-DI and UDI-DI identify, how they connect to UDI carriers, EUDAMED records, change triggers, and retained evidence. - [MDR vs AI Act for medical-device software](/artifacts/eu/medical-device-regulation/mdr-vs-ai-act.md): Compare MDR software qualification, classification, clinical evidence, QMS, PMS, UDI, EUDAMED, and notified-body evidence boundaries against cautiously scoped AI Act overlap. - [MDR vs GPSR: medical-device boundary checks](/artifacts/eu/medical-device-regulation/mdr-vs-gpsr.md): Compare MDR medical-device scope with general product-safety fallback questions for borderline, non-medical, and Annex XVI products. - [MDR vs IVDR: medical devices and IVDs compared](/artifacts/eu/medical-device-regulation/mdr-vs-ivdr.md): Compare EU MDR and IVDR scope, classification, conformity routes, technical documentation, clinical or performance evidence, UDI, EUDAMED, PMS, and vigilance. - [MDR vs Product Liability Directive evidence comparison](/artifacts/eu/medical-device-regulation/mdr-vs-product-liability-directive.md): Compare EU MDR market-access evidence with Product Liability Directive exposure without treating compliance records as a liability outcome. - [What should an EU MDR PMCF plan and report cover? | EU MDR FAQ](/artifacts/eu/medical-device-regulation/faq/pmcf.md): Under the EU MDR, PMCF is part of PMS and clinical evaluation. See what the plan, activities, report, updates, and retained evidence should cover. - [What should manufacturers do when an EU MDR classification changes? | EU MDR FAQ](/artifacts/eu/medical-device-regulation/faq/class-changes.md): Concise EU MDR FAQ on classification changes, intended purpose, software, notified-body route impact, certificates, technical documentation, and retained evidence. - [When can clinical equivalence be used under the EU MDR?](/artifacts/eu/medical-device-regulation/faq/equivalence.md): EU MDR FAQ on clinical equivalence, including technical, biological, and clinical characteristics, access to equivalent-device data, class III and implantable-device limits, clinical evaluation, PMCF, and retained evidence. - [When do software or products make medical purpose claims under the EU MDR? | EU MDR FAQ](/artifacts/eu/medical-device-regulation/faq/medical-purpose-claims.md): EU MDR FAQ on medical purpose claims, intended purpose evidence, software qualification, Annex XVI contrasts, and records to keep. - [When is a PSUR required under the EU MDR and what should it contain? | EU MDR FAQ](/artifacts/eu/medical-device-regulation/faq/psur.md): EU MDR FAQ on PSUR scope, content, update cadence, PMS and PMCF links, notified-body handling, EUDAMED submission, and evidence to retain. - [When is an accessory regulated under the EU MDR? | EU MDR FAQ](/artifacts/eu/medical-device-regulation/faq/accessories.md): EU MDR FAQ on when an article is a medical device accessory, how intended purpose affects classification, and what evidence to keep. - [When is software regulated as SaMD under the EU MDR? | EU MDR FAQ](/artifacts/eu/medical-device-regulation/faq/software-and-samd.md): Concise EU MDR FAQ on software qualification, intended medical purpose, Rule 11 classification, modules, clinical evidence, change assessment, UDI, and EUDAMED. - [Which devices need an SSCP under the EU MDR and what should it include? | EU MDR FAQ](/artifacts/eu/medical-device-regulation/faq/sscp.md): EU MDR FAQ on when an SSCP is required, who prepares, validates, uploads, and updates it, and what evidence should support the summary. - [Which EUDAMED modules matter under the EU MDR? | EU MDR FAQ](/artifacts/eu/medical-device-regulation/faq/eudamed-modules.md): EU MDR FAQ mapping EUDAMED modules to actor registration, UDI/device data, certificates, clinical investigations, vigilance/PMS, market surveillance, and practical records. --- [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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