---
title: "EU MDR compliance obligations"
canonical_url: "https://www.sorena.io/artifacts/eu/medical-device-regulation/compliance"
source_url: "https://www.sorena.io/artifacts/eu/medical-device-regulation/compliance"
author: "Sorena AI"
description: "EU MDR compliance guide for device qualification, classification, conformity assessment, QMS, technical documentation, UDI, EUDAMED, PMS, vigilance, and legacy transition controls."
published_at: "2026-05-09"
updated_at: "2026-05-09"
keywords:
  - "EU MDR"
  - "Regulation (EU) 2017/745"
  - "MDR compliance"
  - "medical device classification"
  - "notified body"
  - "EUDAMED"
  - "UDI"
  - "EU Medical Device Regulation"
  - "medical device conformity assessment"
---
**[SORENA](https://www.sorena.io/)** - AI-Powered GRC Platform

[Home](https://www.sorena.io/) | [Solutions](https://www.sorena.io/solutions) | [Artifacts](https://www.sorena.io/artifacts) | [About Us](https://www.sorena.io/about-us) | [Contact](https://www.sorena.io/contact) | [Portal](https://app.sorena.io)

---

# 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.

*Artifact Guide* *EU*

## EU Medical Device Regulation Compliance

A cited MDR compliance map for qualification, risk class, conformity assessment route, QMS controls, technical documentation, clinical evidence, UDI, EUDAMED, PMS, vigilance, and legacy-device conditions.

Use it to check whether an EU medical-device file contains the decisions and evidence that regulators, notified bodies, importers, distributors, and customers are likely to ask for.

EU MDR compliance is not one certificate or one policy. A manufacturer needs a documented chain from intended purpose and qualification through classification, conformity assessment, QMS, technical documentation, clinical evidence, UDI, EUDAMED registration, post-market surveillance, vigilance, and any legacy-device transition claim.

## 1. Confirm qualification, role, and risk class

Start with the product's intended purpose, claims, software functions, accessory status, and EU market role. The MDR covers medical devices and accessories placed on the Union market, and it also reaches certain Annex XVI products without an intended medical purpose once common specifications apply.

Classification must be documented against Annex VIII. The MDR divides devices into classes I, IIa, IIb, and III by intended purpose and inherent risk. That classification drives the conformity assessment route, notified-body involvement, clinical evidence depth, PMS reporting, and UDI/EUDAMED timing.

- Keep a qualification memo with intended purpose, indications, user population, claims, accessories, software modules, data inputs and outputs, and any non-medical Annex XVI rationale.
- Record the Annex VIII rule or rules applied, why a higher-risk rule does or does not control, and who approved the classification.
- For software, record whether each module has its own medical purpose, merely stores or transfers information, drives or influences another device, or changes the device's intended purpose or safety/performance characteristics.
- Map the EU economic-operator roles separately: manufacturer, authorised representative, importer, distributor, and any party relabelling, repackaging, or selling under its own name.

Sources for this answer:

- [Regulation (EU) 2017/745 on medical devices](https://eur-lex.europa.eu/eli/reg/2017/745/oj?ref=sorena.io) - Primary MDR source for device scope, Annex XVI products, Article 51 classification, Annex VIII classification rules, and manufacturer obligations.

## 2. Select the conformity assessment and notified-body route

The conformity route follows the risk class and device type. Class I devices generally remain under manufacturer responsibility unless a specific feature triggers notified-body involvement, while class IIa, IIb, and III devices require an appropriate level of notified-body involvement under Article 52.

Do not treat a notified-body certificate as a substitute for the manufacturer's compliance file. The manufacturer remains responsible for conformity, the CE marking, technical documentation, the EU declaration of conformity, and keeping the notified body informed where the chosen procedure requires it.

- Identify the Article 52 route and the relevant annex procedure before release planning, procurement commitments, or customer launch dates are fixed.
- Verify that the notified body is designated for Regulation (EU) 2017/745 and for the relevant device scope, not just generally listed as a conformity assessment body.
- Keep the application, certificate, surveillance scope, technical-documentation sampling records, design-examination records where applicable, and change notifications together with the product file.
- For CE-marked devices involving a notified body, keep the notified body's identification number aligned across certificate, label, instructions for use, declaration of conformity, and promotional material.

Sources for this answer:

- [Regulation (EU) 2017/745 on medical devices](https://eur-lex.europa.eu/eli/reg/2017/745/oj?ref=sorena.io) - Primary MDR source for Article 52 conformity assessment, notified-body involvement, CE marking, certificates, and EU declaration obligations.
- [European Commission - notified bodies for medical devices](https://health.ec.europa.eu/medical-devices-topics-interest/notified-bodies-medical-devices_en?ref=sorena.io) - Commission source for what notified bodies do, how designation works, and where designated MDR notified bodies are published.

## 3. Build the QMS, technical documentation, GSPR, risk, and clinical evidence file

Article 10 requires manufacturers to establish and maintain risk management, clinical evaluation, UDI and registration obligations, technical documentation, a quality management system, PMS, and incident and field safety corrective-action reporting. The QMS should be proportionate to the risk class and type of device, but it still needs controlled procedures and records.

The technical file should connect Annex I general safety and performance requirements to design inputs, risk controls, verification and validation, standards or common specifications, labelling, instructions for use, clinical evaluation, and PMS feedback. Clinical evaluation under Article 61 must support the GSPR conformity claim with sufficient clinical evidence unless a justified exception is documented in the technical documentation.

- Maintain a GSPR matrix that links each applicable Annex I requirement to design evidence, risk controls, verification or validation evidence, labelling, and clinical evidence.
- Keep Annex II technical documentation and Annex III PMS documentation current after design changes, supplier changes, standard changes, complaints, incidents, PMCF findings, or new clinical data.
- Document risk management as a living file: hazards, foreseeable misuse, benefit-risk conclusions, residual risks, risk-control verification, and PMS inputs that reopen the analysis.
- Use harmonised standards as evidence only where the cited OJEU reference and standard edition match the requirement being claimed; record any alternative technical solution where standards are not used or do not cover the full requirement.

Sources for this answer:

- [Regulation (EU) 2017/745 on medical devices](https://eur-lex.europa.eu/eli/reg/2017/745/oj?ref=sorena.io) - Primary MDR source for Article 10 manufacturer obligations, Annex I GSPR, Annex II technical documentation, Annex III PMS documentation, and Article 61 clinical evaluation.
- [European Commission - harmonised standards overview](https://single-market-economy.ec.europa.eu/single-market/goods/european-standards/harmonised-standards_en?ref=sorena.io) - Commission source for the role of harmonised standards and voluntary use of standards to demonstrate compliance with EU legal requirements.

*Recommended next step*

*Placement: after implementation section*

## Review the MDR evidence chain before release

Check qualification, class, conformity route, QMS controls, technical documentation, clinical evidence, UDI, EUDAMED, PMS, vigilance, and any legacy-device claim as one connected compliance file.

- [Open EU MDR Research Copilot](/solutions/research-copilot.md): Answer EU MDR scope, timing, and interpretation questions with cited outputs.
- [Talk through EU MDR implementation](/contact.md): Review your scope, evidence model, controls, and next actions.

## 4. Control UDI, EUDAMED, PMS, and vigilance obligations

UDI and EUDAMED records should be treated as regulatory master data, not as final-form administrative uploads. Article 27 ties UDI to serious-incident and field safety corrective-action reporting, and manufacturers must keep an up-to-date list of assigned UDIs in the technical documentation.

PMS must be planned, documented, implemented, maintained, and updated for each device as part of the QMS. When PMS identifies preventive or corrective action, the manufacturer must implement appropriate measures and inform competent authorities and, where applicable, the notified body. Serious incidents and field safety corrective actions are reported under Article 87.

- Assign Basic UDI-DI and UDI-DI records before the relevant conformity-assessment and registration steps, and keep the Basic UDI-DI aligned across certificate, declaration of conformity, technical documentation, SSCP where applicable, and EUDAMED.
- Keep EUDAMED actor registration, UDI/device registration, notified-body certificate references, and market-surveillance records under change control with named data owners.
- Run PMS against a documented plan, with inputs from complaints, servicing, user feedback, literature, registries, PMCF, trend analysis, and corrective actions.
- Maintain vigilance triage records showing incident awareness date, causality assessment, serious-incident decision, reportability rationale, field safety corrective action, competent-authority communication, and linkage to UDI.

Sources for this answer:

- [Regulation (EU) 2017/745 on medical devices](https://eur-lex.europa.eu/eli/reg/2017/745/oj?ref=sorena.io) - Primary MDR source for Article 27 UDI, Article 83 PMS, Article 87 serious-incident and field safety corrective-action reporting, and technical-documentation updates.
- [MDCG 2022-7 - UDI system Q&A](https://health.ec.europa.eu/system/files/2022-05/mdcg_2022-7_en.pdf?ref=sorena.io) - MDCG source for Basic UDI-DI, UDI-DI, declaration of conformity references, and UDI data governance questions.
- [EUDAMED - European Database on Medical Devices](https://webgate.ec.europa.eu/eudamed?ref=sorena.io) - Official EUDAMED portal source for the six modules and the mandatory use of the first four modules from 28 May 2026.

## 5. Govern legacy-device and evidence-change decisions

Legacy transition claims need their own evidence register. Regulation (EU) 2023/607 extended transitional provisions for certain devices, but only where the conditions are met, including no significant change in design and intended purpose, QMS implementation by 26 May 2024, formal notified-body application by 26 May 2024, and a written notified-body agreement by 26 September 2024 where the transition path requires it.

Treat every compliance conclusion as versioned evidence. The most important governance control is the trigger list: design or intended-purpose change, software functionality change, new clinical evidence, supplier or manufacturing change, harmonised-standard change, complaint trend, serious incident, field safety corrective action, notified-body finding, or EUDAMED data correction.

- For each legacy device, keep the old certificate, declaration of conformity, device class, Article 120 pathway, QMS evidence, notified-body application, written agreement, surveillance-transfer arrangement, and significant-change assessment.
- Do not reuse a legacy transition rationale after a design or intended-purpose change unless the significant-change assessment is reopened and documented.
- Keep evidence ownership explicit: regulatory owns qualification and classification, quality owns QMS and PMS procedures, clinical owns clinical evaluation and PMCF, engineering owns design and verification evidence, and operations owns UDI/EUDAMED data quality.
- Use release gates that prevent shipment when the file lacks a current classification decision, applicable conformity-assessment route, GSPR matrix, clinical-evidence conclusion, UDI/EUDAMED record, PMS plan, or vigilance procedure.

Sources for this answer:

- [Regulation (EU) 2023/607 on MDR and IVDR transitional provisions](https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A32023R0607&ref=sorena.io) - Binding amendment source for legacy-device transition conditions, QMS and notified-body application timing, written agreement timing, and significant-change limits.
- [Regulation (EU) 2017/745 on medical devices](https://eur-lex.europa.eu/eli/reg/2017/745/oj?ref=sorena.io) - Primary MDR source for technical documentation retention, competent-authority requests, PMS updates, vigilance, and notified-body surveillance context.

## Primary sources

- [Regulation (EU) 2017/745 on medical devices](https://eur-lex.europa.eu/eli/reg/2017/745/oj?ref=sorena.io) - Primary MDR source for scope, manufacturer obligations, classification, conformity assessment, technical documentation, clinical evaluation, UDI, PMS, vigilance, and EUDAMED provisions.
  - Quote: "laying down rules concerning the placing on the market"
- [European Commission - notified bodies for medical devices](https://health.ec.europa.eu/medical-devices-topics-interest/notified-bodies-medical-devices_en?ref=sorena.io) - Commission source for notified-body designation, conformity-assessment role, NANDO listing references, monitoring, and published standard-fee information.
  - Quote: "assess the conformity of certain products before being placed on the market"
- [European Commission - harmonised standards overview](https://single-market-economy.ec.europa.eu/single-market/goods/european-standards/harmonised-standards_en?ref=sorena.io) - Commission source for harmonised-standard use, OJEU references, and voluntary standard-based demonstration of compliance.
  - Quote: "use harmonised standards to demonstrate that products"
- [MDCG 2022-7 - UDI system Q&A](https://health.ec.europa.eu/system/files/2022-05/mdcg_2022-7_en.pdf?ref=sorena.io) - MDCG source for Basic UDI-DI, UDI-DI, declaration of conformity references, certificates, SSCP, PSUR, and UDI data governance.
  - Quote: "Basic UDI-DI is the main key"
- [EUDAMED - European Database on Medical Devices](https://webgate.ec.europa.eu/eudamed?ref=sorena.io) - Official EUDAMED portal source for system purpose, six-module structure, access controls, and mandatory use of the first four modules from 28 May 2026.
  - Quote: "living picture of the lifecycle of medical devices"
- [Regulation (EU) 2023/607 on MDR and IVDR transitional provisions](https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A32023R0607&ref=sorena.io) - Binding amendment source for certain MDR legacy-device transition conditions, QMS timing, notified-body application and agreement timing, and significant-change limits.
  - Quote: "transitional provisions for certain medical devices"

## Related 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 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.


---

[Privacy Policy](https://www.sorena.io/privacy.md) | [Terms of Use](https://www.sorena.io/terms-of-use.md) | [DMCA](https://www.sorena.io/dmca.md) | [About Us](https://www.sorena.io/about-us.md)

(c) 2026 Sorena AB (559573-7338). All rights reserved.

Source: https://www.sorena.io/artifacts/eu/medical-device-regulation/compliance.md