DeadlinesEU

EU Medical Device Regulation (MDR) 2017/745 Deadlines and Compliance Calendar

Turn MDR dates into deliverables, owners, and gates.

Focus: Article 120 legacy-device milestones, notified body and QMS cutoffs, class III custom-made implantable timing, and the staged EUDAMED rollout.

Back to main artifactReview sources
Author
Sorena AI
Published
Feb 22, 2026
Updated
Feb 22, 2026
Sections
4

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

Regulatory dates don't help unless they create action. Use this page as a planning layer: map each milestone to deliverables (technical file, clinical evaluation, PMS readiness), owners, and decision points (classification changes, notified body route, legacy device transition eligibility).

Section 1

Baseline MDR timeline (anchor dates you should use in planning)

These are the dates that should anchor your planning assumptions. Your device-specific calendar still depends on classification, conformity route, certificate history, and whether you are relying on Article 120 legacy-device transition.

Control: keep a date-assumptions section in your compliance plan so regulatory, quality, clinical, supply-chain, and product teams use the same calendar.

  • 26 May 2021: MDR date of application. Use this as the baseline for default MDR obligations and for identifying legacy devices.
  • 20 March 2023: Regulation (EU) 2023/607 entered into force. Recheck certificate status, pending applications, and transition assumptions from this date forward.
  • 9 July 2024: Regulation (EU) 2024/1860 entered into force and became the legal basis for the gradual EUDAMED rollout.
  • 28 May 2026: the first four EUDAMED modules become mandatory to use, so actor, device, certificate, and market-surveillance data readiness should be on your live compliance calendar.
Recommended next step

Turn EU Medical Device Regulation (MDR) 2017/745 Deadlines and Compliance Calendar into an operational assessment

Assessment Autopilot can take EU Medical Device Regulation (MDR) 2017/745 Deadlines and Compliance Calendar 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.

Assessment workflow
Open Assessment Autopilot for EU Medical Device Regulation (MDR) 2017/745 Deadlines and Compliance Calendar

Start from EU Medical Device Regulation (MDR) 2017/745 Deadlines and Compliance Calendar and turn the guidance into owned tasks, evidence requests, and review checkpoints.

Explore next step
Talk to Sorena
Talk through EU Medical Device Regulation (MDR) 2017/745

Review your current process, evidence gaps, and next steps for EU Medical Device Regulation (MDR) 2017/745 Deadlines and Compliance Calendar.

Explore next step
Section 2

Legacy devices and transition milestones (practical calendar items)

For legacy devices, dates only matter if you can prove the Article 120 conditions behind them. Missing one condition can collapse the whole transition path.

Control: maintain a legacy-device eligibility dossier with certificate history, change assessments, QMS evidence, and notified-body documents.

  • 26 May 2024: the manufacturer needed to have an MDR QMS in place under Article 10(9) and, where Article 120(3c)(e) applied, a formal notified-body application lodged by this date.
  • 26 September 2024: the written agreement with the MDR notified body had to be signed by this date, and the incoming MDR notified body becomes responsible for the appropriate surveillance at the latest by then.
  • 31 December 2027 or 31 December 2028: the transition end date depends on MDR Annex VIII classification logic, not simply the old directive certificate label.
  • 26 May 2026: special transition endpoint for class III custom-made implantable devices if the manufacturer met the 2024 application and written-agreement deadlines.
  • No sell-off deadline: devices lawfully placed on the market before the end of transition may continue to be made available or put into service without a fixed sell-off end date, subject to shelf-life or expiry.
Section 3

What to deliver before each milestone (use as calendar tasks)

Convert each date into a named evidence package. If you cannot attach a document list, owner, and review gate to the milestone, the calendar entry is too vague.

Tip: schedule an internal audit-style review before each external deadline so date pressure does not hide evidence gaps.

  • Article 120 eligibility pack: certificate history, lawful placing-on-the-market evidence, significant-change assessments, and legacy-device scope statement.
  • QMS readiness pack: Article 10(9) procedures, PRRC coverage, PMS and vigilance procedures, UDI controls, and management-review records.
  • Notified-body application pack: scope memo, classification memo, technical-file index, CER status, PMS-plan status, and submitted-application evidence.
  • Surveillance-transfer pack: written agreement, tripartite transfer arrangements where relevant, and clear responsibility mapping after 26 September 2024.
  • UDI and EUDAMED readiness pack: SRN records, Basic UDI-DI strategy, device-master-data controls, and label-release checks tied to submissions.
Section 4

EUDAMED milestone planning (do not leave it to the end)

EUDAMED is now a staged implementation program, not a distant future system. Your planning should distinguish the first four mandatory modules from the later clinical-investigation and vigilance milestones.

Control: create one EUDAMED readiness board that tracks actor registration, UDI and device data, certificate references, and the interim process for modules that are not yet mandatory.

  • Plan actor registration first. Manufacturers, authorised representatives, and importers need the right legal-entity mapping and SRN governance before device records can stay clean.
  • Prepare master data for the first four mandatory modules: Actor Registration, UDI and Device Registration, Notified Bodies and Certificates, and Market Surveillance.
  • Keep an interim vigilance and PSUR visibility process with the notified body until the Post-market Surveillance and Vigilance module becomes mandatory to use.
  • Align label artwork, Basic UDI-DI governance, and software-version controls with the UDI and device-registration process.
  • Train backup users and access approvers now. EUDAMED access, delegation, and correction rights are operational controls, not admin detail.
Primary sources

References and citations

Related guides

Explore more topics

Applicability Test | EU Medical Device Regulation (MDR) 2017/745 | Is it a Medical Device? Annex XVI? Software Rule 11?
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)
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
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
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
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.
Device Classification Guide | EU Medical Device Regulation (MDR) 2017/745 | Annex VIII + Software Rule 11
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
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
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
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
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
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
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
A grounded MDR requirements guide for Regulation (EU) 2017/745: scope and role mapping, Annex VIII classification, Article 10 and 15 governance.
Transition Timelines | EU Medical Device Regulation (MDR) 2017/745 | Legacy Devices, 2023/607 Extension, Significant Changes
A practical MDR transition and legacy-device timeline guide: how Article 120 works after Regulation (EU) 2023/607, which conditions must stay true.
UDI and EUDAMED | EU Medical Device Regulation (MDR) 2017/745 | UDI-DI/PI, Basic UDI-DI, Actor Registration, Device Registration
A practical MDR UDI and EUDAMED guide: Basic UDI-DI, UDI-DI, UDI-PI, actor registration and SRN, Article 29 device registration.