---
title: "EU MDR PMS and Vigilance Guide"
canonical_url: "https://www.sorena.io/artifacts/eu/medical-device-regulation/pms-and-vigilance"
source_url: "https://www.sorena.io/artifacts/eu/medical-device-regulation/pms-and-vigilance"
author: "Sorena AI"
description: "EU MDR guide to post-market surveillance, PMCF updates, PMS reports, PSURs, serious incident reporting, FSCA/FSN handling, trend reporting, and evidence records."
published_at: "2026-05-09"
updated_at: "2026-05-09"
keywords:
  - "EU MDR PMS"
  - "EU MDR vigilance"
  - "post-market surveillance"
  - "PMCF"
  - "PSUR"
  - "PMS report"
  - "serious incident"
  - "FSCA"
  - "FSN"
  - "trend reporting"
  - "EU MDR"
  - "Regulation (EU) 2017/745"
  - "vigilance"
  - "field safety corrective action"
---
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---

# EU MDR PMS and Vigilance Guide

EU MDR guide to post-market surveillance, PMCF updates, PMS reports, PSURs, serious incident reporting, FSCA/FSN handling, trend reporting, and evidence records.

*Artifact Guide* *EU MDR*

## EU MDR PMS and Vigilance

EU MDR post-market work is not only complaint handling. Manufacturers need a documented PMS system and plan that actively collects safety and performance data, updates technical documentation and clinical evaluation, and feeds vigilance decisions.

Use this page to structure PMS plans, PMCF updates, PMS reports or PSURs, serious incident and FSCA reporting, trend reporting, EUDAMED caveats, and the evidence records reviewers will expect.

Under EU MDR Articles 83 to 89, PMS and vigilance are linked systems: PMS continuously gathers and analyses market data, while vigilance escalates serious incidents, field safety corrective actions, field safety notices, and reportable trends. The practical control is a traceable record from complaint or signal through evaluation, reportability decision, CAPA or FSCA, clinical evaluation update, and technical documentation update.

## PMS system and plan

For each device, the manufacturer must plan, establish, document, implement, maintain, and update a PMS system proportionate to risk class and device type. The system belongs inside the quality management system and must actively and systematically gather, record, and analyse quality, performance, and safety data throughout the device lifetime.

The PMS plan is the operating document for that system. Annex III expects it to cover serious incidents, PSUR information, FSCAs, non-serious incidents, undesirable side-effects, trend reporting, literature, registers or databases, user feedback, complaints, distributor and importer inputs, public information about similar devices, assessment methods, indicators, thresholds, complaint investigation tools, communication methods, corrective-action procedures, traceability tools, and a PMCF plan or a justified reason why PMCF is not applicable.

- Define PMS data streams before launch: complaints, support cases, service records, distributor/importer feedback, literature searches, registries, similar-device signals, vigilance events, CAPA, PMCF outputs, and sales or exposure data.
- Set device-specific indicators and threshold values for benefit-risk reassessment instead of relying on open-ended complaint review.
- Document how the team characterises performance, compares the device with similar products, investigates complaints, escalates trend signals, and traces devices that may need corrective action.
- Keep the PMS plan in technical documentation for non-custom-made devices and update the technical documentation when PMS data changes risk management, clinical evaluation, labelling, IFU, SSCP, CAPA, or FSCA conclusions.

Sources for this answer:

- [Regulation (EU) 2017/745 on medical devices](https://eur-lex.europa.eu/eli/reg/2017/745/oj?ref=sorena.io) - Articles 83 and 84 require a documented PMS system and PMS plan; Annex III lists the PMS plan data streams, methods, thresholds, communication methods, corrective-action procedures, traceability tools, and PMCF linkage.

*Recommended next step*

*Placement: after evidence section*

## Review EU MDR PMS and vigilance evidence

Map PMS data streams, PMCF updates, PMS report or PSUR outputs, vigilance triage, FSCA/FSN handling, trend thresholds, and EUDAMED or alternative submission records into one reviewable evidence trail.

- [Open EU MDR Research Copilot](/solutions/research-copilot.md): Answer MDR PMS, PMCF, PSUR, vigilance, and EUDAMED questions with cited outputs.
- [Talk through MDR implementation](/contact.md): Review PMS and vigilance scope, evidence records, reporting routes, and next actions.

## PMCF and clinical evaluation updates

PMCF is a continuous process that updates the clinical evaluation. It must be addressed in the PMS plan and uses clinical data from real use of the CE-marked device within its intended purpose to confirm safety and performance, keep identified risks acceptable, and detect emerging risks.

The PMCF plan should be device-specific. It should name the general methods, such as clinical experience, user feedback, scientific literature, and other clinical data sources, plus any specific methods such as registries or PMCF studies. It should also connect to the clinical evaluation report and risk management file, explain why the chosen methods are appropriate, and define a justified schedule for PMCF activities and reporting.

- Record the device description, intended purpose, target population, indications, contraindications, and accessories covered by the PMCF scope.
- Tie every PMCF activity to a reason: clinical evaluation gaps, risk management findings, previous PMCF results, PMS signals, notified-body requests, or unanswered safety and performance questions.
- Analyse PMCF findings in a PMCF evaluation report and feed the conclusions into the clinical evaluation report, technical documentation, and risk management.
- When PMCF is not planned, keep the justification in the PMS plan and expect it to be reviewed with the clinical evaluation and risk file.

Sources for this answer:

- [Regulation (EU) 2017/745 on medical devices](https://eur-lex.europa.eu/eli/reg/2017/745/oj?ref=sorena.io) - Article 61 and Annex XIV require clinical evaluation to be updated with PMCF and PMS data and require PMCF plans, PMCF evaluation reports, and technical documentation updates.
- [MDCG 2020-7 - PMCF plan template](https://health.ec.europa.eu/medical-devices-sector/new-regulations/guidance-mdcg-endorsed-documents-and-other-guidance_en/document/download/a5cdb303-c782-4010-8723-7d389af678f7_en?filename=md_mdcg_2020_7_guidance_pmcf_plan_template_en.pdf&ref=sorena.io) - MDCG 2020-7 provides a PMCF plan structure covering manufacturer details, device description, general and specific PMCF methods, links to technical documentation, equivalent or similar device data, standards or guidance, and the estimated PMCF evaluation report date.

## PMS report and PSUR outputs

The output changes by device class. Class I manufacturers prepare a PMS report that summarises PMS data analysis, conclusions, and the rationale and description for preventive or corrective actions. Class IIa, IIb, and III manufacturers prepare a PSUR for each device and, where relevant, each category or group of devices.

A PSUR should summarise PMS analysis, conclusions, preventive and corrective actions, benefit-risk conclusions, main PMCF findings, sales volume, estimated population using the device, population characteristics, and usage frequency where practicable. MDCG 2022-21 treats the PSUR as a stand-alone, organised, searchable document that summarises results and conclusions rather than duplicating every PMS record.

- For class IIb and class III devices, update the PSUR at least annually; for class IIa devices, update it when necessary and at least every two years.
- For class III and implantable devices, MDR Article 86 routes PSUR submission through the Article 92 electronic system to the notified body; for other PSUR devices, make PSURs available to the notified body and competent authorities upon request.
- Until EUDAMED is fully functional for the relevant PSUR workflow, MDCG 2022-21 says manufacturers should apply national provisions and agree appropriate submission means with the notified body where needed.
- Keep the PSUR/PMS report connected to the PMS plan data collection period so reviewers can see which signals were included, which were excluded, and why.

Sources for this answer:

- [Regulation (EU) 2017/745 on medical devices](https://eur-lex.europa.eu/eli/reg/2017/745/oj?ref=sorena.io) - Articles 85 and 86 define the PMS report for class I devices, PSUR duties for class IIa, IIb, and III devices, update frequency, PSUR content, and availability or submission routes.
- [MDCG 2022-21 - PSUR guidance](https://health.ec.europa.eu/medical-devices-sector/new-regulations/guidance-mdcg-endorsed-documents-and-other-guidance_en/document/download/a7df24c3-d4a3-4218-a8e0-726febfa01c2_en?filename=mdcg_2022-21_en.pdf&ref=sorena.io) - MDCG 2022-21 explains PSUR objectives, grouping, content, data presentation, issuance, EUDAMED submission scenarios, and the absence-of-EUDAMED approach.

## Serious incidents, FSCAs, FSNs, and trend reporting

Vigilance starts with reportability triage. MDR Article 87 requires manufacturers to report serious incidents involving Union-market devices, except expected side-effects that are clearly documented, quantified in technical documentation, and handled through Article 88 trend reporting. Article 87 also requires reporting of FSCAs for Union-market devices, including third-country FSCAs for a device also legally available in the Union unless the reason is limited to the third-country device.

MDCG 2023-3 frames a reportable serious incident around three checks: an incident occurred, it led or might lead to a serious health or public-health outcome, and a causal relationship with the manufacturer's device is established, reasonably possible, or suspected. If the manufacturer is uncertain whether a potentially reportable incident is reportable, the MDR requires reporting within the applicable timeframe.

- Use Article 87 timelines in the vigilance SOP: serious incidents immediately and no later than 15 calendar days after awareness; serious public health threats immediately and no later than 2 days; death or unanticipated serious deterioration immediately after causality is established or suspected and no later than 10 days after awareness.
- When information is incomplete, submit an initial report on time and follow with additional information rather than waiting for a full root-cause investigation.
- For an FSCA, report in advance unless urgency requires immediate action, then issue an FSN without delay to affected users or customers.
- Make the FSN identify the device, include relevant UDIs, identify the manufacturer by SRN where available, explain the malfunction and associated risks without understating the risk, and state the user actions clearly.
- For trend reporting, define in the PMS plan the incidents, expected undesirable side-effects, statistical method, thresholds, and observation period used to detect significant increases affecting benefit-risk.

Sources for this answer:

- [Regulation (EU) 2017/745 on medical devices](https://eur-lex.europa.eu/eli/reg/2017/745/oj?ref=sorena.io) - Articles 87, 88, and 89 define serious incident and FSCA reporting, trend reporting, investigations, FSN content, and competent-authority evaluation.
- [MDCG 2023-3 Rev. 2 - vigilance terms and concepts](https://health.ec.europa.eu/medical-devices-sector/new-regulations/guidance-mdcg-endorsed-documents-and-other-guidance_en/document/download/af1433fd-ed64-4c53-abc7-612a7f16f976_en?filename=mdcg_2023-3_en.pdf&ref=sorena.io) - MDCG 2023-3 explains serious incident criteria, reportability uncertainty, awareness-date logic, calendar-day timing, expected side-effects, FSCAs, FSNs, evaluating competent authorities, and periodic summary reporting.

## Evidence records to keep

A defensible PMS and vigilance file should show the route from signal to decision. Keep the raw signal, triage, reportability assessment, trend calculation, risk analysis, benefit-risk conclusion, CAPA or FSCA decision, communications, authority submissions, notified-body interactions, and the updates made to clinical evaluation and technical documentation.

EUDAMED is part of the MDR reporting architecture, but practical submissions may depend on module availability and transitional guidance. Keep evidence of the route used: EUDAMED submission receipts where applicable, national or notified-body submission records where EUDAMED is not the operative route, and the rationale for the route selected.

- PMS system and PMS plan versions, with approval history and links to QMS procedures.
- Complaint, feedback, literature, registry, public database, distributor/importer, service, and sales/exposure data used in PMS analysis.
- Clinical evaluation updates, PMCF plan, PMCF evaluation report, and justification for any PMCF not performed.
- PMS report or PSUR versions, data collection periods, grouping rationale, benefit-risk conclusion, CAPA summary, PMCF findings, sales volume, population estimate, and usage-frequency basis.
- Vigilance records: MIRs, initial and follow-up reports, final reports, FSCA forms, FSNs, draft FSN authority comments, distribution evidence, UDI/SRN references, authority correspondence, and periodic summary reporting agreements where used.
- Trend-reporting workpapers showing expected frequency or severity, actual counts, statistical method, observation period, threshold breach analysis, and whether the benefit-risk analysis changed.

Sources for this answer:

- [Regulation (EU) 2017/745 on medical devices](https://eur-lex.europa.eu/eli/reg/2017/745/oj?ref=sorena.io) - Annex III requires PMS technical documentation to be clear, organised, searchable, and unambiguous; Articles 83 to 89 specify the records needed to support PMS, PSUR/PMS report, trend, serious incident, FSCA, and FSN decisions.
- [EUDAMED information centre](https://webgate.ec.europa.eu/eudamed-help/en/welcome-to-the-eudamed-information-centre.html?ref=sorena.io) - The EUDAMED information centre describes the system, its lifecycle role, and its modules, including vigilance and post-market surveillance, which supports the caveat to keep route evidence for EUDAMED or alternative submissions.
- [MDCG 2022-21 - PSUR guidance](https://health.ec.europa.eu/medical-devices-sector/new-regulations/guidance-mdcg-endorsed-documents-and-other-guidance_en/document/download/a7df24c3-d4a3-4218-a8e0-726febfa01c2_en?filename=mdcg_2022-21_en.pdf&ref=sorena.io) - MDCG 2022-21 identifies PSUR evidence elements such as device scope, reference number, version, data collection period, grouping rationale, sales volume, population estimate, vigilance data, CAPA, PMCF findings, and benefit-risk conclusion.

## 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 PMS system and plan duties, PMS report, PSUR, serious incident reporting, FSCA/FSN handling, trend reporting, PMCF linkage, and PMS technical documentation.
  - Quote: "post-market surveillance system"
- [MDCG 2020-7 - PMCF plan template](https://health.ec.europa.eu/medical-devices-sector/new-regulations/guidance-mdcg-endorsed-documents-and-other-guidance_en/document/download/a5cdb303-c782-4010-8723-7d389af678f7_en?filename=md_mdcg_2020_7_guidance_pmcf_plan_template_en.pdf&ref=sorena.io) - MDCG template source for PMCF plan sections, methods, links to technical documentation, and PMCF evaluation report planning.
  - Quote: "PMCF plan shall be part"
- [MDCG 2022-21 - PSUR guidance](https://health.ec.europa.eu/medical-devices-sector/new-regulations/guidance-mdcg-endorsed-documents-and-other-guidance_en/document/download/a7df24c3-d4a3-4218-a8e0-726febfa01c2_en?filename=mdcg_2022-21_en.pdf&ref=sorena.io) - MDCG guidance source for PSUR objectives, content, grouping, preparation, EUDAMED scenarios, and absence-of-EUDAMED handling.
  - Quote: "Periodic Safety Update Report"
- [MDCG 2023-3 Rev. 2 - vigilance terms and concepts](https://health.ec.europa.eu/medical-devices-sector/new-regulations/guidance-mdcg-endorsed-documents-and-other-guidance_en/document/download/af1433fd-ed64-4c53-abc7-612a7f16f976_en?filename=mdcg_2023-3_en.pdf&ref=sorena.io) - MDCG guidance source for serious incident criteria, reporting uncertainty, awareness-date timing, FSCAs, FSNs, evaluating competent authorities, and periodic summary reports.
  - Quote: "vigilance terms and concepts"
- [EUDAMED information centre](https://webgate.ec.europa.eu/eudamed-help/en/welcome-to-the-eudamed-information-centre.html?ref=sorena.io) - Commission EUDAMED source for the database lifecycle role and module context, including vigilance and post-market surveillance.
  - Quote: "European Database on 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): source-linked 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 source-linked 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): source-linked 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): source-linked 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): Grounded 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): source-linked 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): source-linked 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): source-linked 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 records](/artifacts/eu/medical-device-regulation/post-market-surveillance-and-vigilance.md): source-linked 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 source-linked 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, source-linked 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.


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