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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.

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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 risk to the health or safety of patients, users, or other persons or to other aspects of public-health protection, 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 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 (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.
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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.

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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 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 or justification why PMCF is not applicable, 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 and no later than two days after awareness of 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.
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