MDRFree Resource

EU Medical Device Regulation (MDR) Timeline and Decision Flow

Use this artifact to confirm MDR scope, including Annex XVI products, identify your economic operator role, and map a workable MDR route for CE marking, technical documentation, clinical evaluation, PMS, vigilance, UDI, EUDAMED, and legacy transition decisions.

MDR has applied since 26 May 2021. Legacy-device transition now depends on Article 120 conditions, the 26 May 2024 and 26 September 2024 cutoffs, and the staged EUDAMED rollout that makes the first four modules mandatory from 28 May 2026.

Run the MDR applicability test
Publication details
Editorial metadata for this artifact
Author
Sorena AI
Published
Feb 22, 2026
Updated
Feb 22, 2026
What you can decide faster
Is it a medical device (or Annex XVI product)
Scope, intended purpose, borderline cases, and Annex XVI common specifications.
Your role and obligations
Manufacturer, authorised representative, importer, distributor - and what changes if you relabel or modify.
Classification to conformity route
Annex VIII classification (incl. software Rule 11) and Annex IX/X/XI evidence routes.
By Sorena AIUpdated 2026No signup required
Quick scan
MDR
Scope + role
Confirm medical-device scope, Annex XVI edge cases, and operator responsibilities.
Transition + evidence
Test Article 120 eligibility, then align technical file, CER, and PMS evidence.
Traceability + reporting
Plan UDI, EUDAMED, vigilance, PSUR, and actor-registration operations.
Use the topic guides to turn MDR obligations into owners, evidence, and an execution plan.
2017
Regulation
2021
Applies
UDI
Traceability
EUDAMED
Registration
Scope first
Classification
Evidence planning
MDR Timeline

Key dates for device compliance

Track application, transitional provisions, and operational milestones that affect certification planning, evidence readiness, and lifecycle obligations.

Loading timeline...
MDR Decision Flow

Which MDR obligations apply to your device

Use the decision flow to confirm scope, role, classification, and route assumptions, then identify the evidence you need across design, release, and post-market operations.

Loading decision map...

Topic guides

Deep dive pages for implementation planning, controls, reporting, and evidence.

1
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.
Read Guide
2
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.
Read Guide
3
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).
Read Guide
4
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.
Read Guide
5
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.
Read Guide
6
Deadlines and Compliance Calendar | EU Medical Device Regulation (MDR) 2017/745 | Transition, Legacy Devices, EUDAMED
A practical MDR deadlines and compliance calendar: MDR application timing, Regulation (EU) 2023/607 transition conditions.
Read Guide
7
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.
Read Guide
8
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.
Read Guide
9
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.
Read Guide
10
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.
Read Guide
11
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.
Read Guide
12
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.
Read Guide
13
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.
Read Guide
14
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.
Read Guide
15
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.
Read Guide
16
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.
Read Guide
Next step

Turn EU Medical Device Regulation (MDR) Timeline and Decision Flow into an operational assessment workflow

EU Medical Device Regulation (MDR) Timeline and Decision Flow should be the shared entry point for your team. Route execution into Assessment Autopilot for live work and into SSOT when the artifact needs deeper research, evidence governance, or supporting analysis.

What this unlocks
  • Start from EU Medical Device Regulation (MDR) Timeline and Decision Flow and route the work by entity, product, team, or control owner.
  • Use Assessment Autopilot to turn the guidance into owned tasks, evidence requests, and review checkpoints.
  • Use SSOT to keep documents, evidence, and control records in one governed system.
  • Move from artifact reading to accountable execution without rebuilding the guidance in separate files.
Recommended route
Open Assessment Autopilot
Turn the guidance into owned tasks, evidence requests, and review checkpoints for EU Medical Device Regulation (MDR) Timeline and Decision Flow.
Supporting route
Open SSOT
Keep documents, evidence, and control records in one governed system from the same artifact.
Talk to Sorena
Talk through EU Medical Device Regulation (MDR) Timeline and Decision Flow
Review your current process, evidence model, and next steps for EU Medical Device Regulation (MDR) Timeline and Decision Flow.
Discuss your setup
EU MDR artifact preview
Share it internally
Download the artifact exports to align legal, product, engineering, and commercial teams.