---
title: "EU Medical Device Regulation (MDR) 2017/745 Compliance Hub"
canonical_url: "https://www.sorena.io/artifacts/eu/medical-device-regulation"
source_url: "https://www.sorena.io/artifacts/eu/medical-device-regulation"
author: "Sorena AI"
description: "EU MDR hub for Regulation (EU) 2017/745: device qualification, risk classification, conformity assessment, notified bodies, technical documentation, clinical evaluation, UDI, EUDAMED, PMS, vigilance and legacy-device transition."
published_at: "2026-02-22"
updated_at: "2026-05-26"
keywords:
  - "EU MDR"
  - "Regulation (EU) 2017/745"
  - "medical device qualification"
  - "MDR classification"
  - "Annex VIII"
  - "conformity assessment"
  - "notified body"
  - "technical documentation"
  - "clinical evaluation"
  - "UDI"
  - "EUDAMED"
  - "PMS"
  - "vigilance"
  - "legacy devices"
  - "MDR"
  - "Medical devices"
  - "CE marking"
  - "Post-market surveillance"
---
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---

# EU Medical Device Regulation (MDR) 2017/745 Compliance Hub

EU MDR hub for Regulation (EU) 2017/745: device qualification, risk classification, conformity assessment, notified bodies, technical documentation, clinical evaluation, UDI, EUDAMED, PMS, vigilance and legacy-device transition.

![EU MDR artifact preview](https://cdn.sorena.io/cdn-cgi/image/format=auto/cheatsheets/prod/sorena-ai-eu-mdr-timeline-small.jpg?v=cheatsheets%2Fprod)

*MDR* *Regulation (EU) 2017/745*

## EU Medical Device Regulation Compliance Hub

This MDR hub (Regulation (EU) 2017/745) helps confirm whether your product is a medical device, accessory or Annex XVI product, then plan classification, conformity assessment and evidence.

Practical guidance to validate against your own legal requirements; confirm intended purpose, justify the Annex VIII risk class, and keep technical and clinical records current.

[Run the MDR applicability test](/artifacts/eu/medical-device-regulation/applicability-test.md)

## What this hub helps you check

- **Device qualification and scope**: Confirm medical purpose, accessory status, software function, Annex XVI coverage, borderline signals, and the economic-operator role for the EU market route.
- **Risk class and conformity route**: Apply Annex VIII classification, including software Rule 11 where relevant, then map the result to the MDR conformity assessment route and notified body involvement.
- **Lifecycle evidence**: Tie technical documentation, clinical evaluation, PMCF, PMS, PSUR where applicable, vigilance, UDI assignment, EUDAMED registration and legacy-transition records to one controlled device history.

By Sorena AI | Based on official EU sources | No signup required

### Quick scan

*MDR*

- **Start with intended purpose**: The MDR qualification question turns on what the manufacturer intends the product to do for human beings. Software, accessories and Annex XVI products need the same disciplined scope record before classification or CE planning.
- **Classify before choosing the route**: Classification is not a label exercise. Record the applicable Annex VIII rule, invasiveness, duration of use, active or implantable status, substance or nanomaterial features, software decision impact, and any rule that drives a higher class.
- **Build a living evidence file**: Keep Annex II and III technical documentation, risk management, GSPR mapping, clinical evaluation report, PMCF plan or rationale, PMS plan, vigilance procedure, UDI data and EUDAMED actor/device records aligned with the released device.

Use the topic guides to move from MDR scope and classification into technical-file readiness, notified body planning, clinical evidence, PMS/vigilance operations, UDI/EUDAMED setup and legacy-device transition checks.

| Value | Metric |
| --- | --- |
| 2017/745 | Regulation |
| Annex VIII | Classification |
| Annex II + III | Technical file |
| Article 61 | Clinical evaluation |
| UDI | Traceability |

**Key highlights:** Qualify device scope | Classify risk | Prepare evidence

## 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 medical-device scope, economic-operator duties, classification, conformity assessment, technical documentation, clinical evaluation, post-market surveillance, vigilance, UDI, EUDAMED and transitional provisions.
  - Quote: "rules for the placing on the market"
- [Regulation (EU) 2023/607 on MDR transitional provisions](https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A32023R0607&ref=sorena.io) - Supports the legacy-device framing, including Article 120 conditions, QMS and notified body application milestones, extended transitional periods, surveillance transfer logic and removal of the former sell-off limit.
  - Quote: "extend the validity of certificates"
- [Commission Implementing Regulation (EU) 2022/2346](https://data.europa.eu/eli/reg_impl/2022/2346/oj?ref=sorena.io) - Grounds the Annex XVI references for products without an intended medical purpose, common specifications, risk management expectations and clinical evaluation considerations for non-medical purpose products.
  - Quote: "common specifications for the groups of products"
- [European Commission EUDAMED portal](https://webgate.ec.europa.eu/eudamed?ref=sorena.io) - Supports the EUDAMED overview, including the six module areas for actor registration, UDI/device registration, notified bodies and certificates, clinical investigations, vigilance/PMS and market surveillance.
  - Quote: "EUDAMED is composed of six modules"
- [European Commission UDI/Device registration page](https://health.ec.europa.eu/medical-devices-eudamed/udidevice-registration_en?ref=sorena.io) - Supports the hub's UDI and EUDAMED device-registration references, including manufacturer submission of UDI/device information and use of the UDI/device registration module.
  - Quote: "manufacturers submit in EUDAMED the UDI/Device information"
- [European Commission notified bodies for medical devices](https://health.ec.europa.eu/medical-devices-topics-interest/notified-bodies-medical-devices_en?ref=sorena.io) - Supports the notified body discussion, including designation by Member States, conformity assessment tasks where third-party intervention is required and use of NANDO lists for MDR-designated bodies.
  - Quote: "assess the conformity of certain products"
- [MDCG 2023-6 guidance on Annex XVI equivalence](https://health.ec.europa.eu/system/files/2023-12/mdcg_2023-6_en.pdf?ref=sorena.io) - Supports the Annex XVI clinical-evidence caution: equivalence for products without an intended medical purpose requires careful comparison, and clinical data from medical devices may not be sufficient for non-medical purpose products.
  - Quote: "demonstration of equivalence for Annex XVI products"
- [MDCG 2022-7 questions and answers on UDI](https://health.ec.europa.eu/system/files/2022-05/mdcg_2022-7_en.pdf?ref=sorena.io) - Supports the UDI implementation references and the need to treat UDI assignment, labelling and device data as controlled traceability evidence rather than a late formatting task.
  - Quote: "questions and answers on the UDI system"

## 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 deadlines and compliance calendar](/artifacts/eu/medical-device-regulation/deadlines-and-compliance-calendar.md): Official source EU MDR calendar for application, legacy-device transition, UDI, EUDAMED, and recurring QMS, technical documentation, clinical, PMS, vigilance, certificate, and change reviews.
- [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.

## Key records for medical device compliance

*MDR Reference Points*

Track MDR application, Article 120 legacy-device conditions, notified body application and agreement evidence, technical documentation updates, clinical evaluation and PMCF outputs, PMS/vigilance records, UDI assignment, EUDAMED actor and device registration, certificate status, and market-surveillance correspondence for each device family.

*Next step*

## Turn MDR scope and evidence into owned device work

This hub helps route MDR work by device family, intended purpose, risk class, economic-operator role, notified body status, clinical evidence route and EU market path. The output should be a controlled device file, not a one-time checklist.

- Start with the product boundary, intended purpose, claims, user population, EU market route, manufacturer and economic-operator roles, Annex XVI or software signals, and any borderline facts that change qualification.
- Use Assessment Autopilot to request classification rationale, applicable Annex VIII rules, GSPR mapping, risk management records, Annex II and III technical documentation, clinical evaluation, PMCF or justification, PMS plan, PSUR where applicable, vigilance process, UDI data and EUDAMED registration evidence.
- Use Research Copilot for cited questions about MDR scope, Annex XVI common specifications, Rule 11 software classification, notified body designation scope, conformity assessment routes, clinical evidence expectations, EUDAMED modules and Article 120 legacy-device conditions.
- Keep design, quality, regulatory, clinical, post-market, distributor, importer, notified body and authority-response records connected to the same device model and Basic UDI-DI.

- [Open Assessment Autopilot](/solutions/assessment.md): Turn MDR scope, classification, technical documentation, clinical evaluation, PMS, vigilance, UDI and EUDAMED records into owned tasks and review checkpoints.
- [Open Research Copilot](/solutions/research-copilot.md): Answer MDR scope, classification, conformity assessment, notified body, clinical evidence and legacy-transition questions with cited outputs from official sources.
- **Download MDR reference points**: Align MDR application, Article 120 transition checks, certification work, EUDAMED module readiness and lifecycle evidence across regulatory, quality and clinical teams.
- [Talk through MDR readiness](/contact.md): Review your device scope, classification rationale, notified body path, technical file, clinical evidence model, PMS/vigilance process and UDI/EUDAMED setup.

## Compliance Timeline

| Date | Event | Category | Reference |
| --- | --- | --- | --- |
| 2017-04-05 | MDR Adopted | Adoption & Publication | [Source](https://eur-lex.europa.eu/eli/reg/2017/745/oj?ref=sorena.io) |
| 2017-05-05 | MDR Published in Official Journal | Adoption & Publication | [Source](https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=OJ:L:2017:117:TOC&ref=sorena.io) |
| 2017-05-25 | MDR Entry Into Force | Adoption & Publication | [Source](https://eur-lex.europa.eu/eli/reg/2017/745/oj?ref=sorena.io) |
| 2017-11-26 | EU MDR device codes and corresponding device types deadline | Application Dates | [Source](https://eur-lex.europa.eu/eli/reg/2017/745/oj?ref=sorena.io) |
| 2017-11-26 | Notified Body Framework Starts Applying | Application Dates | [Source](https://eur-lex.europa.eu/eli/reg/2017/745/oj?ref=sorena.io) |
| 2018-05-26 | EUDAMED Implementation Plan Due | EUDAMED System | [Source](https://eur-lex.europa.eu/eli/reg/2017/745/oj?ref=sorena.io) |
| 2018-05-26 | Cooperation Rules Start Applying | Application Dates | [Source](https://eur-lex.europa.eu/eli/reg/2017/745/oj?ref=sorena.io) |
| 2019-05-26 | UDI Issuing Entities Interim Rule Starts | Key Deadlines | [Source](https://eur-lex.europa.eu/eli/reg/2017/745/oj?ref=sorena.io) |
| 2019-06-27 | UDI Issuing Entities Designated | Key Deadlines | [Source](https://eur-lex.europa.eu/eli/dec_impl/2019/939/oj/eng?ref=sorena.io) |
| 2020-04-24 | COVID-19 MDR Postponement Enters Into Force | Application Dates | [Source](https://eur-lex.europa.eu/eli/reg/2020/561/oj?ref=sorena.io) |
| 2020-08-20 | Single-Use Reprocessing Common Specifications Published | Guidance & Implementation | [Source](https://eur-lex.europa.eu/eli/reg_impl/2020/1207/oj/eng?ref=sorena.io) |
| 2020-09-09 | Single-Use Reprocessing Common Specifications Enter Into Force | Application Dates | [Source](https://eur-lex.europa.eu/eli/reg_impl/2020/1207/oj/eng?ref=sorena.io) |
| 2021-03-25 | EUDAMED Full Functionality Notice Target Updated | EUDAMED System | [Source](https://eur-lex.europa.eu/eli/reg/2020/561/oj?ref=sorena.io) |
| 2021-05-26 | MDR Date of Application | Application Dates | [Source](https://eur-lex.europa.eu/eli/reg/2020/561/oj?ref=sorena.io) |
| 2021-05-26 | UDI Carrier Starts for Implantable and Class III Devices | Key Deadlines | [Source](https://eur-lex.europa.eu/eli/reg/2017/745/oj?ref=sorena.io) |
| 2021-05-26 | Single-Use Reprocessing Common Specifications Apply | Application Dates | [Source](https://eur-lex.europa.eu/eli/reg_impl/2020/1207/oj/eng?ref=sorena.io) |
| 2021-12-19 | EUDAMED Access and Use Rules Enter Into Force | EUDAMED System | [Source](https://eur-lex.europa.eu/eli/reg_impl/2021/2078/oj?ref=sorena.io) |
| 2022-12-01 | Annex XVI Common Specifications Adopted | Guidance & Implementation | [Source](https://eur-lex.europa.eu/eli/reg_impl/2022/2346/oj?ref=sorena.io) |
| 2022-12-02 | Annex XVI Common Specifications Published | Guidance & Implementation | [Source](https://eur-lex.europa.eu/eli/reg_impl/2022/2346/oj?ref=sorena.io) |
| 2022-12-22 | Annex XVI Regulation Enters Into Force | Application Dates | [Source](https://eur-lex.europa.eu/eli/reg_impl/2022/2346/oj?ref=sorena.io) |
| 2023-03-15 | Transitional Period Amendment Adopted | Transitional Provisions | [Source](https://eur-lex.europa.eu/eli/reg/2023/607/oj?ref=sorena.io) |
| 2023-03-20 | Transitional Extension Enters Into Force | Transitional Provisions | [Source](https://eur-lex.europa.eu/eli/reg/2023/607/oj?ref=sorena.io) |
| 2023-05-26 | UDI Carrier Expands to Class IIa and IIb Devices | Key Deadlines | [Source](https://eur-lex.europa.eu/eli/reg/2017/745/oj?ref=sorena.io) |
| 2023-05-26 | Reusable Implantable and Class III Direct Marking Starts | Key Deadlines | [Source](https://eur-lex.europa.eu/eli/reg/2017/745/oj?ref=sorena.io) |
| 2023-06-21 | Annex XVI Transition Amendment Published | Transitional Provisions | [Source](https://eur-lex.europa.eu/eli/reg_impl/2023/1194/oj?ref=sorena.io) |
| 2023-06-22 | Annex XVI Common Specifications Apply | Application Dates | [Source](https://eur-lex.europa.eu/eli/reg_impl/2022/2346/oj?ref=sorena.io) |
| 2024-05-26 | Legacy Transition QMS and Application Deadline | Key Deadlines | [Source](https://eur-lex.europa.eu/eli/reg/2023/607/oj?ref=sorena.io) |
| 2024-05-27 | Commission Report Due on Single-Use Reprocessing | Key Deadlines | [Source](https://eur-lex.europa.eu/eli/reg/2017/745/oj?ref=sorena.io) |
| 2024-06-22 | Annex XVI Clinical Investigation Notification Condition Starts | Transitional Provisions | [Source](https://eur-lex.europa.eu/eli/reg_impl/2022/2346/oj?ref=sorena.io) |
| 2024-07-09 | EUDAMED Gradual Rollout Amendment Enters Into Force | EUDAMED System | [Source](https://eur-lex.europa.eu/eli/reg/2024/1860/oj?ref=sorena.io) |
| 2024-09-26 | Legacy Transition Written Agreement Deadline | Key Deadlines | [Source](https://eur-lex.europa.eu/eli/reg/2023/607/oj?ref=sorena.io) |
| 2024-12-22 | Annex XVI Clinical Investigation Notification Condition Ends | Transitional Provisions | [Source](https://eur-lex.europa.eu/eli/reg_impl/2022/2346/oj?ref=sorena.io) |
| 2024-12-23 | Annex XVI Clinical Investigation Start Condition Begins | Transitional Provisions | [Source](https://eur-lex.europa.eu/eli/reg_impl/2023/1194/oj?ref=sorena.io) |
| 2025-05-26 | UDI Carrier Expands to Class I Devices | Key Deadlines | [Source](https://eur-lex.europa.eu/eli/reg/2017/745/oj?ref=sorena.io) |
| 2025-05-26 | Reusable Class IIa and IIb Direct Marking Starts | Key Deadlines | [Source](https://eur-lex.europa.eu/eli/reg/2017/745/oj?ref=sorena.io) |
| 2025-11-27 | EUDAMED Four-Module Functionality Notice Published | EUDAMED System | [Source](https://eur-lex.europa.eu/eli/dec/2025/2371/oj/eng?ref=sorena.io) |
| 2026-05-26 | Class III Custom-Made Implants Transition Ends | Key Deadlines | [Source](https://eur-lex.europa.eu/eli/reg/2023/607/oj?ref=sorena.io) |
| 2026-05-28 | First Four EUDAMED Modules Mandatory | EUDAMED System | [Source](https://health.ec.europa.eu/latest-updates/eudamed-four-first-modules-will-be-mandatory-use-28-may-2026-2025-11-27_en?ref=sorena.io) |
| 2027-01-01 | Annex XVI No-Investigation Written Agreement Condition Starts | Transitional Provisions | [Source](https://eur-lex.europa.eu/eli/reg_impl/2023/1194/oj?ref=sorena.io) |
| 2027-05-26 | EU MDR Article 78 coordinated assessment procedure starts applying | Application Dates | [Source](https://eur-lex.europa.eu/eli/reg/2017/745/oj?ref=sorena.io) |
| 2027-05-26 | Reusable Class I Direct Marking Starts | Key Deadlines | [Source](https://eur-lex.europa.eu/eli/reg/2017/745/oj?ref=sorena.io) |
| 2027-12-31 | Annex XVI Clinical Investigation Start Condition Ends | Transitional Provisions | [Source](https://eur-lex.europa.eu/eli/reg_impl/2023/1194/oj?ref=sorena.io) |
| 2027-12-31 | Legacy Class III and Implantables Transition Ends | Transitional Provisions | [Source](https://eur-lex.europa.eu/eli/reg/2023/607/oj?ref=sorena.io) |
| 2028-01-01 | Annex XVI Clinical-Investigation Written Agreement Condition Begins | Transitional Provisions | [Source](https://eur-lex.europa.eu/eli/reg_impl/2023/1194/oj?ref=sorena.io) |
| 2028-12-31 | Remaining Legacy Devices Transition Ends | Transitional Provisions | [Source](https://eur-lex.europa.eu/eli/reg/2023/607/oj?ref=sorena.io) |
| 2028-12-31 | Annex XVI No-Investigation Transition Ends | Transitional Provisions | [Source](https://eur-lex.europa.eu/eli/reg_impl/2023/1194/oj?ref=sorena.io) |
| 2029-12-31 | Annex XVI Clinical-Investigation Transition Ends | Transitional Provisions | [Source](https://eur-lex.europa.eu/eli/reg_impl/2023/1194/oj?ref=sorena.io) |

**Event details:**

- **2017-04-05 - MDR Adopted**: Regulation (EU) 2017/745 on medical devices was adopted by the European Parliament and Council.
- **2017-05-05 - MDR Published in Official Journal**: Regulation (EU) 2017/745 was published in OJ L 117.
- **2017-05-25 - MDR Entry Into Force**: Regulation (EU) 2017/745 entered into force 20 days after publication.
- **2017-11-26 - EU MDR device codes and corresponding device types deadline**: The Commission deadline to draw up, by implementing acts, a list of codes and corresponding device types.
- **2017-11-26 - Notified Body Framework Starts Applying**: Articles 35 to 50 on notified bodies and Articles 101 and 103 on competent authorities and the MDCG started applying.
- **2018-05-26 - EUDAMED Implementation Plan Due**: Commission deadline to draw up the implementation plan for EUDAMED functional specifications.
- **2018-05-26 - Cooperation Rules Start Applying**: Article 102 on cooperation between competent authorities and the Commission started applying.
- **2019-05-26 - UDI Issuing Entities Interim Rule Starts**: Article 120(12) started applying: until Commission designation, GS1, HIBCC and ICCBBA were treated as designated issuing entities.
- **2019-06-27 - UDI Issuing Entities Designated**: Commission Implementing Decision (EU) 2019/939 designated GS1 AISBL, HIBCC, ICCBBA and IFA GmbH as issuing entities for UDI systems.
- **2020-04-24 - COVID-19 MDR Postponement Enters Into Force**: Regulation (EU) 2020/561 entered into force on publication and postponed the MDR date of application from 26 May 2020 to 26 May 2021.
- **2020-08-20 - Single-Use Reprocessing Common Specifications Published**: Commission Implementing Regulation (EU) 2020/1207 on common specifications for reprocessing single-use devices was published.
- **2020-09-09 - Single-Use Reprocessing Common Specifications Enter Into Force**: Commission Implementing Regulation (EU) 2020/1207 entered into force 20 days after publication and later applied from 26 May 2021.
- **2021-03-25 - EUDAMED Full Functionality Notice Target Updated**: Regulation (EU) 2020/561 amended Article 34 to replace the original 25 March 2020 target with 25 March 2021.
- **2021-05-26 - MDR Date of Application**: The MDR became applicable on 26 May 2021 after the COVID-19 postponement amendment.
- **2021-05-26 - UDI Carrier Starts for Implantable and Class III Devices**: Article 27(4) started applying for implantable devices and class III devices.
- **2021-05-26 - Single-Use Reprocessing Common Specifications Apply**: Commission Implementing Regulation (EU) 2020/1207 became applicable from the MDR date of application.
- **2021-12-19 - EUDAMED Access and Use Rules Enter Into Force**: Commission Implementing Regulation (EU) 2021/2078 entered into force with rules for EUDAMED access, use and related IT functions.
- **2022-12-01 - Annex XVI Common Specifications Adopted**: Commission Implementing Regulation (EU) 2022/2346 laid down common specifications for Annex XVI products without an intended medical purpose.
- **2022-12-02 - Annex XVI Common Specifications Published**: Commission Implementing Regulation (EU) 2022/2346 was published in the Official Journal.
- **2022-12-22 - Annex XVI Regulation Enters Into Force**: Commission Implementing Regulation (EU) 2022/2346 entered into force; Article 2(3) applied from the same date.
- **2023-03-15 - Transitional Period Amendment Adopted**: Regulation (EU) 2023/607 was adopted to extend certain MDR and IVDR transitional provisions and remove sell-off deadlines.
- **2023-03-20 - Transitional Extension Enters Into Force**: Regulation (EU) 2023/607 entered into force on publication in the Official Journal.
- **2023-05-26 - UDI Carrier Expands to Class IIa and IIb Devices**: Article 27(4) started applying for class IIa and class IIb devices.
- **2023-05-26 - Reusable Implantable and Class III Direct Marking Starts**: For reusable devices requiring the UDI carrier on the device itself, Article 27(4) started two years later for implantable and class III devices.
- **2023-06-21 - Annex XVI Transition Amendment Published**: Commission Implementing Regulation (EU) 2023/1194 was published and entered into force, amending the Annex XVI transition windows in Regulation (EU) 2022/2346.
- **2023-06-22 - Annex XVI Common Specifications Apply**: Commission Implementing Regulation (EU) 2022/2346 became applicable, except for provisions with specific application dates.
- **2024-05-26 - Legacy Transition QMS and Application Deadline**: Manufacturers relying on extended Article 120 transition periods must have put in place an MDR-compliant QMS and lodged a formal conformity assessment application by this date.
- **2024-05-27 - Commission Report Due on Single-Use Reprocessing**: Deadline for the Commission report on the operation of Article 17 on reprocessing of single-use devices.
- **2024-06-22 - Annex XVI Clinical Investigation Notification Condition Starts**: For relevant Annex XVI products using the clinical investigation route, the Member State notification condition runs from 22 June 2024 to 22 December 2024.
- **2024-07-09 - EUDAMED Gradual Rollout Amendment Enters Into Force**: Regulation (EU) 2024/1860 entered into force, enabling mandatory use of individual EUDAMED modules after functionality notices and transition periods.
- **2024-09-26 - Legacy Transition Written Agreement Deadline**: Manufacturers and notified bodies must have signed the written conformity assessment agreement; Article 120 also transfers appropriate surveillance by this date where applicable.
- **2024-12-22 - Annex XVI Clinical Investigation Notification Condition Ends**: End of the Annex XVI transition period that requires a Member State notification confirming the clinical investigation application is complete and within scope.
- **2024-12-23 - Annex XVI Clinical Investigation Start Condition Begins**: For relevant Annex XVI products using the clinical investigation route, the sponsor must have started the clinical investigation from 23 December 2024 until 31 December 2027.
- **2025-05-26 - UDI Carrier Expands to Class I Devices**: Article 27(4) started applying for class I devices.
- **2025-05-26 - Reusable Class IIa and IIb Direct Marking Starts**: For reusable devices requiring the UDI carrier on the device itself, Article 27(4) started two years later for class IIa and class IIb devices.
- **2025-11-27 - EUDAMED Four-Module Functionality Notice Published**: Commission Decision (EU) 2025/2371 declared the Actor, UDI/Devices, Notified Bodies and Certificates, and Market Surveillance electronic systems functional.
- **2026-05-26 - Class III Custom-Made Implants Transition Ends**: End of the Article 120 transition period for class III custom-made implantable devices where the extended-transition conditions are met.
- **2026-05-28 - First Four EUDAMED Modules Mandatory**: The Actor, UDI/Devices, Notified Bodies and Certificates, and Market Surveillance modules become mandatory to use.
- **2027-01-01 - Annex XVI No-Investigation Written Agreement Condition Starts**: For relevant Annex XVI products not requiring a clinical investigation route, the written agreement condition runs from 1 January 2027 until 31 December 2028.
- **2027-05-26 - EU MDR Article 78 coordinated assessment procedure starts applying**: The procedure set out in Article 78 started applying under the Article 123 derogations.
- **2027-05-26 - Reusable Class I Direct Marking Starts**: For reusable devices requiring the UDI carrier on the device itself, Article 27(4) started two years later for class I devices.
- **2027-12-31 - Annex XVI Clinical Investigation Start Condition Ends**: End of the Annex XVI transition period where the sponsor must have started the clinical investigation for products using that route.
- **2027-12-31 - Legacy Class III and Implantables Transition Ends**: End of the Article 120 transition period for class III devices and class IIb implantable devices, except the listed lower-risk class IIb implantables, where conditions are met.
- **2028-01-01 - Annex XVI Clinical-Investigation Written Agreement Condition Begins**: For relevant Annex XVI products using the clinical investigation route, the written agreement condition runs from 1 January 2028 until 31 December 2029.
- **2028-12-31 - Remaining Legacy Devices Transition Ends**: End of the Article 120 transition period for remaining covered legacy devices, including other class IIb devices, class IIa devices, relevant class I sterile or measuring devices, and MDD self-declared devices that require notified-body involvement under the MDR, where conditions are met.
- **2028-12-31 - Annex XVI No-Investigation Transition Ends**: End of the Annex XVI transitional period for relevant products where the conformity assessment route does not require a clinical investigation.
- **2029-12-31 - Annex XVI Clinical-Investigation Transition Ends**: Final transition deadline for relevant Annex XVI products using the clinical investigation route and meeting the Article 2 transition conditions.


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