Compliance CalendarEU 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.

Back to main artifactReview sources
Author
Sorena AI
Published
May 9, 2026
Updated
Jul 24, 2026
Sections
3

Structured answer sets in this page tree.

Primary sources
5

Cited legal and guidance references.

Publication metadata
Sorena AI
Published May 9, 2026
Updated Jul 24, 2026
Overview

Use 26 May 2021 as the MDR application date, 31 December 2027 or 31 December 2028 as the conditional legacy-device endpoint for the applicable device group, and the class-specific UDI and PSUR cycles shown below. The first four EUDAMED modules became mandatory on 28 May 2026. This calendar separates those legal dates from device-specific review triggers and does not invent national filing windows or project milestones.

Section 1

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
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
Grounds the one-year postponement that moved MDR application for medical devices to 26 May 2021.
Recommended next step

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.

Research workflow
Open Research Copilot

Answer MDR timing and transition questions with cited outputs.

Explore next step
Talk to Sorena
Talk through implementation

Review your device calendar, source evidence, and operating controls.

Explore next step
Section 2

UDI and EUDAMED calendar entries

Track UDI and EUDAMED separately from the legacy-device transition. The class-based dates below apply to MDR-compliant devices. Commission Q&A states that legacy devices using Article 120 are not subject to the MDR UDI requirements during the extended transition, so do not apply the carrier dates to a legacy device without first confirming its regulatory status.

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 began for the first four EUDAMED modules: Actor, UDI/Devices, Notified Bodies and Certificates, and Market Surveillance.
Sources for this answer
European Commission - EUDAMED
Confirms that the Actor, UDI/Devices, Notified Bodies and Certificates, and Market Surveillance modules became mandatory on 28 May 2026.
Regulation (EU) 2017/745 on medical devices
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.
European Commission Q&A on Regulation (EU) 2023/607
Explains that legacy devices benefiting from Article 120 transition are not subject to MDR UDI requirements during the extended transitional period.
Section 3

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.
  • Actor-registration data: update changed registration information within one week. Confirm accuracy no later than one year after the first submission and every second year after that; retain the EUDAMED confirmation evidence.
  • 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. For class III and implantable devices, update the PMCF evaluation report and, if indicated, the SSCP at least annually.
  • PMS output cycle: update class IIb and class III PSURs at least annually. Update class IIa PSURs when necessary and at least every two years. Update a class I PMS report when necessary rather than assigning it an unsupported annual cycle.
  • PMS and vigilance review: review post-production experience, complaints, incidents, field safety corrective actions, PMCF outputs, and preventive or corrective actions. Article 87 sets event-specific reporting periods, including immediate reporting for a serious public-health threat and no later than 15 days for other serious incidents, subject to the shorter 10-day period for death or an unanticipated serious deterioration in health.
  • 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
Grounds ongoing QMS, technical documentation, PMS, vigilance, UDI database, clinical evaluation, and PMCF review obligations.
Regulation (EU) 2023/607 on MDR transitional provisions
Grounds the need to monitor legacy-device transition conditions, significant changes, notified-body agreements, and surveillance transfer.
Primary sources

References and citations

European Commission - EUDAMED
health.ec.europa.eu
Referenced sections
  • Confirms that the Actor, UDI/Devices, Notified Bodies and Certificates, and Market Surveillance modules became mandatory on 28 May 2026.
Related guides

Explore more topics

Custom-made medical devices under the EU MDR | EU MDR FAQ
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
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
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
EU MDR guide for Annex XVI products: listed groups, common specifications, binding reclassification rules, clinical evidence, notified-body route, transition conditions, UDI, EUDAMED, PMS, and vigilance.
EU MDR Applicability Test
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
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
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
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
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
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
EU MDR guide to clinical evaluation, clinical investigations, equivalence, PMCF, GSPR support, technical documentation, and notified-body review.
EU MDR compliance obligations
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
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
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
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
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
EU MDR legacy-device guide to Article 120 eligibility, class-based end dates, certificate validity, significant changes, surveillance, and evidence.
EU MDR notified body route selection
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
EU MDR guide to Article 113 national penalties, authority measures, recalls, certificate action, and the evidence needed for a country-specific assessment.
EU MDR PMS and Vigilance Guide
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
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
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
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
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
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
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
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
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
FAQ on MDR significant changes for legacy devices, including intended-purpose, design, software, material, sterilisation, clinical, QMS, notified-body, and evidence impacts.
EU MDR SSCP: Devices and Requirements
Decide whether an EU medical device needs an SSCP, see worked class IIa, IIb, and III examples, and check the required content, evidence, publication, and update controls.
EU MDR transition timeline and end dates
EU MDR chronology for 2021 application, 2023 amendments, 2024 eligibility milestones, and conditional 2026, 2027, and 2028 legacy-device endpoints.
EU MDR UDI and EUDAMED registration guide
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
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
EU MDR FAQ on Basic UDI-DI grouping, device and package UDI-DIs, UDI carriers, EUDAMED registration, change triggers, and required records.
MDR vs AI Act for medical-device software
Compare MDR and AI Act scope, high-risk classification, conformity assessment, evidence, monitoring, and timing for AI-enabled medical devices.
MDR vs EU Product Liability Directive
Compare MDR compliance evidence with EU product-liability claims, responsible parties, disclosure, presumptions, damage, and the December 2026 transition.
MDR vs GPSR: medical-device boundary checks
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
Compare EU MDR and IVDR scope, classification, conformity routes, technical documentation, clinical or performance evidence, UDI, EUDAMED, PMS, and vigilance.
What should an EU MDR PMCF plan and report cover? | EU MDR FAQ
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
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?
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
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
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
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 a medical device under the EU MDR?
EU MDR FAQ on medical device software qualification, Rule 11 and other classification rules, modules, evidence, software changes, UDI, and EUDAMED.
Which EUDAMED modules matter under the EU MDR? | EU MDR FAQ
EU MDR FAQ mapping EUDAMED modules to actor registration, UDI/device data, certificates, clinical investigations, vigilance/PMS, market surveillance, and practical records.