--- title: "EU MDR PMS Plan Template for Medical Devices" canonical_url: "https://www.sorena.io/artifacts/eu/medical-device-regulation/post-market-surveillance-plan-template" source_url: "https://www.sorena.io/artifacts/eu/medical-device-regulation/post-market-surveillance-plan-template" author: "Sorena AI" description: "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." published_at: "2026-05-09" updated_at: "2026-05-09" keywords: - "EU MDR PMS plan" - "post-market surveillance plan" - "MDR Article 84" - "MDR Annex III" - "PMCF plan" - "PSUR" - "PMS report" - "medical device vigilance" - "EU MDR" - "Regulation (EU) 2017/745" - "post-market surveillance" - "PMS plan" - "PMCF" - "vigilance" --- **[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 PMS Plan Template for Medical Devices 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. *Artifact Template* *EU MDR* ## EU MDR Post-Market Surveillance Plan Template Build the PMS plan around the specific device, its risk class, intended purpose, lifecycle data, PMCF activities, vigilance routes, complaint handling, trend thresholds, and the report output required for its class. The fields below help as a working structure for the technical documentation required by MDR Article 84 and Annex III. This template is for manufacturers drafting or refreshing an EU MDR post-market surveillance plan. It converts MDR Articles 83 to 88 and Annex III into practical PMS plan fields: what device is covered, what data will be collected, how PMCF feeds the clinical evaluation, how complaints and vigilance are routed, and whether the output is a PMS report or PSUR. ## 1. Device scope and plan control Start the PMS plan with a controlled scope record. MDR Annex III expects the PMS plan to prove compliance with the manufacturer's PMS obligations, so reviewers should be able to identify the device and the plan version without relying on project memory. Keep one row per device, Basic UDI-DI, device family, or justified grouping. If a PSUR later covers several devices, keep the grouping rationale traceable to the PMS plan and the PSUR scope. - Plan control: PMS plan number, version, effective date, revision history, approving function, and next planned review. - Manufacturer and operator details: legal manufacturer, SRN where applicable, authorised representative where applicable, PRRC, complaint intake owner, vigilance owner, PMS owner, clinical owner, and notified body contact where applicable. - Device identity: product or trade name, model and type, Basic UDI-DI, variants, configurations, accessories, certificate number if available, nomenclature code, risk class, classification rule, and custom-made status where relevant. - Intended use profile: intended purpose, intended users, intended patient population, medical conditions, indications, contraindications, warnings, expected lifetime, and whether novel product or procedure features change the PMS evidence strategy. - Market scope: EU markets covered, first placing on the market or MDR certification reference, active distribution status, and whether legacy-device PMS, vigilance, registration, or PSUR obligations still need tracking. Sources for this answer: - [Regulation (EU) 2017/745 on medical devices](https://eur-lex.europa.eu/eli/reg/2017/745/oj?ref=sorena.io) - MDR Articles 83 and 84 require a PMS system and PMS plan; Annex III specifies PMS plan content and technical-documentation expectations. - [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%5Fen?filename=md%5Fmdcg%5F2020%5F7%5Fguidance%5Fpmcf%5Fplan%5Ftemplate%5Fen.pdf&ref=sorena.io) - MDCG 2020-7 provides useful device-description fields for the PMCF part of the PMS plan, including intended purpose, Basic UDI-DI, variants, risk class, and expected lifetime. ## 2. PMS objectives and data sources Describe the PMS objective in device-specific terms: collect and analyse quality, performance, safety, clinical, complaint, and market-experience data throughout the device lifetime, then use the results to update risk management, benefit-risk determination, clinical evaluation, labelling, usability, and corrective actions. Do not list data sources as a policy aspiration. For each source, define the owner, source system, review frequency, inclusion rules, analysis method, threshold or signal criterion, and output record. - Safety and performance data: serious incidents, field safety corrective actions, non-serious incidents, undesirable side-effects, trend reports, complaint files, service records, returned-product analysis, CAPA records, and user feedback. - Clinical and scientific data: PMCF activities, registry data, literature searches, case reports, clinical evaluation updates, data on equivalent or similar devices, and publicly available information about similar devices. - Market and operator inputs: feedback from users, distributors, importers, authorised representatives, competent authorities, notified bodies, procurement or support channels, and post-release monitoring. - Analysis method: define how each source is characterised, trended, compared to similar products where relevant, escalated to risk management, and converted into preventive, corrective, or field safety corrective action decisions. - Plan outputs: updated risk management file, clinical evaluation, PMCF evaluation report, instructions for use or labelling changes, SSCP updates where applicable, PMS report, PSUR, vigilance reports, trend reports, and CAPA evidence. Sources for this answer: - [Regulation (EU) 2017/745 on medical devices](https://eur-lex.europa.eu/eli/reg/2017/745/oj?ref=sorena.io) - MDR Article 83 sets the PMS system objective and identifies how PMS data feeds risk management, clinical evaluation, labelling, SSCP, usability, performance, safety, and trend reporting. - [Regulation (EU) 2017/745 Annex III](https://eur-lex.europa.eu/eli/reg/2017/745/oj?ref=sorena.io) - Annex III lists PMS plan information sources, including serious incidents, FSCA data, non-serious incidents, undesirable side-effects, trend reporting, literature, databases, registers, complaints, feedback, and public information on similar devices. ## 3. PMCF link inside the PMS plan The PMS plan should state whether a PMCF plan is included or why PMCF is not applicable. Where PMCF is performed, make the link operational: identify which clinical questions, risks, benefit-risk uncertainties, residual risks, contraindications, side-effects, off-label use signals, or performance claims the PMCF activities are meant to address. For each PMCF activity, capture the method, objective, rationale, known limitation, endpoint, sample or data source, analysis timing, and report output. The PMCF evaluation report should feed the clinical evaluation report, technical documentation, risk management, and PMS report or PSUR. - PMCF decision: PMCF plan included, PMCF not applicable with justification, or PMCF activity carried forward from clinical evaluation, risk management, previous PMS, previous PMCF, or notified-body feedback. - General PMCF methods: clinical experience, user feedback, patient or healthcare-professional surveys, scientific literature screening, case reports, and other clinical data sources. - Specific PMCF methods: device registry, suitable public registry, PMCF study, extended follow-up, retrospective study, real-world evidence analysis, or post-market study where required for the device profile. - PMCF objectives: confirm safety and performance, monitor side-effects and contraindications, identify emerging risks, confirm benefit-risk acceptability, and detect systematic misuse or off-label use. - PMCF cadence: define analysis and reporting timing quarterly or at least yearly where the MDCG PMCF template expects activity timelines, and set an estimated date for the PMCF evaluation report. Sources for this answer: - [Regulation (EU) 2017/745 Annex III](https://eur-lex.europa.eu/eli/reg/2017/745/oj?ref=sorena.io) - Annex III requires the PMS plan to include a PMCF plan as referred to in Annex XIV Part B or a justification that PMCF is not applicable. - [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%5Fen?filename=md%5Fmdcg%5F2020%5F7%5Fguidance%5Fpmcf%5Fplan%5Ftemplate%5Fen.pdf&ref=sorena.io) - MDCG 2020-7 explains PMCF as part of PMS, gives PMCF objectives, and provides fields for methods, rationale, limitations, technical-documentation references, and PMCF evaluation report timing. ## 4. Complaints, vigilance, trend reporting, and CAPA The PMS plan should show how complaint and field data move from intake to classification, investigation, vigilance reporting, trend analysis, CAPA, and technical-documentation updates. This is where many plans fail: they name a complaint procedure but do not define reportability triage, thresholds, observation periods, or evidence records. Use separate decision paths for non-incidents, incidents, serious incidents, expected undesirable side-effects, non-serious incidents subject to trend reporting, field safety corrective actions, and recurring well-documented serious incidents handled through periodic summary reporting where agreed with the competent authority. - Complaint intake fields: source, date received, device identifier, lot or serial number where relevant, reporter type, event description, patient or user outcome, information supplied by the manufacturer involved, and whether a device issue is alleged. - Incident triage: classify whether the information is an incident under MDR Article 2(64), whether it meets serious-incident criteria, whether uncertainty remains, and who approves the reportability decision. - Vigilance route: define MIR preparation, competent-authority destination, notified-body notification where applicable, FSCA and FSN routing, periodic summary reporting conditions, and how national processes or EUDAMED VGL processes are followed when applicable. - Trend reporting method: define the observation period, expected frequency or severity baseline, statistical method, trigger threshold, benefit-risk impact check, and escalation route for trend reports under MDR Article 88. - CAPA and technical-documentation updates: document root-cause investigation, risk assessment, preventive or corrective action, FSCA decision, effectiveness checks, and updates to risk management, clinical evaluation, IFU, labelling, PMS outputs, and PMCF activities. Sources for this answer: - [Regulation (EU) 2017/745 on medical devices](https://eur-lex.europa.eu/eli/reg/2017/745/oj?ref=sorena.io) - MDR Articles 83, 87, and 88 ground CAPA escalation, serious-incident and FSCA reporting, and trend-reporting methods that must be specified in the PMS plan. - [MDCG 2023-3 Rev.2 vigilance Q&A](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%5Fen?filename=mdcg%5F2023-3%5Fen.pdf&ref=sorena.io) - MDCG 2023-3 clarifies incident versus serious incident concepts, reportability uncertainty, complaint and PMS sources, MIR reporting, trend reports, and interim notified-body information handling before mandatory VGL use. ## 5. PMS report or PSUR output The PMS plan should identify the required reporting output before data collection starts. Class I devices use the PMS report under MDR Article 85. Class IIa, IIb, and III devices use the PSUR under MDR Article 86. The plan should also state how the output becomes part of, or is linked to, the technical documentation. For PSUR devices, define the data collection period, preparation period, update frequency, submission or availability route, and any grouping rationale. For class III and implantable devices, include the EUDAMED or notified-body submission logic required by MDR Article 86 and the PSUR guidance. - PMS report path: for class I devices, summarise PMS data analysis, conclusions, and rationale and description for preventive and corrective actions; update when necessary and make available to competent authorities on request. - PSUR path: for class IIa, IIb, and III devices, summarise PMS data analysis, benefit-risk conclusions, main PMCF findings, sales volume, estimated user population, usage frequency where practicable, and preventive or corrective actions. - PSUR update frequency: class IIb and III at least annually; class IIa when necessary and at least every two years; custom-made device PSURs sit in the custom-made device documentation where applicable. - Submission or availability: class III and implantable PSURs are submitted through the Article 92 electronic system to the notified body involved in conformity assessment; other PSURs are made available to the notified body and competent authorities upon request. - PSUR grouping: if one PSUR covers multiple Basic UDI-DIs or device families, justify the grouping, identify the leading device where used, keep device-specific performance data readable, and avoid hiding signals across different risk profiles. Sources for this answer: - [Regulation (EU) 2017/745 on medical devices](https://eur-lex.europa.eu/eli/reg/2017/745/oj?ref=sorena.io) - MDR Articles 85 and 86 define PMS report and PSUR outputs, class-based update frequencies, PSUR content, and submission or availability 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%5Fen?filename=mdcg%5F2022-21%5Fen.pdf&ref=sorena.io) - MDCG 2022-21 provides PSUR scope, grouping, data collection period, issuance, submission, and schedule guidance for MDR and legacy devices. *Recommended next step* *Placement: after PMS report or evidence section* ## Turn the PMS plan into traceable MDR evidence Use Sorena to keep PMS sources, complaint signals, PMCF records, PSUR or PMS report outputs, citations, owners, and review triggers connected across the medical device technical documentation. - [Open Research Copilot](/solutions/research-copilot.md): Answer MDR PMS, PMCF, vigilance, and PSUR questions with cited outputs. - [Talk through implementation](/contact.md): Review your PMS plan scope, evidence model, responsibilities, and review cadence. ## 6. Responsibilities, review cadence, and evidence records Finish the PMS plan with a responsibility matrix and evidence register. The goal is not to name every corporate function; it is to make sure each PMS input, decision, escalation, report, and technical-documentation update has an accountable owner and a retained record. Set review cadence by device risk, PMS signals, PMCF schedule, PSUR or PMS report cycle, notified-body commitments, and design or market changes. Avoid fixed deadlines that are not supported by the device class or source material. - Responsibility matrix: PMS plan owner, QMS owner, complaint handler, vigilance reporter, PRRC, clinical evaluation owner, PMCF owner, risk management owner, regulatory affairs owner, post-market data analyst, CAPA owner, and final approver. - Scheduled review triggers: PMS report update, PSUR cycle, PMCF evaluation report date, management review, notified-body surveillance, risk-management review, clinical evaluation update, and defined trend-observation periods. - Event-driven review triggers: serious incident, FSCA, trend threshold breach, repeated complaint pattern, new or changed risk, label or IFU change, intended-purpose change, design or supplier change, new clinical evidence, registry signal, authority request, or notified-body feedback. - Evidence register: approved PMS plan, data-source inventory, raw-data extracts or query records, complaint files, vigilance decisions, MIR or FSCA records, trend calculations, CAPA records, PMCF plan and evaluation report, PMS report or PSUR, technical-documentation updates, and approval history. - Traceability rule: every conclusion in the PMS report or PSUR should trace back to a PMS data source, analysis method, date range, owner, and decision record. Sources for this answer: - [Regulation (EU) 2017/745 Annex III](https://eur-lex.europa.eu/eli/reg/2017/745/oj?ref=sorena.io) - Annex III requires clear, organised, searchable PMS technical documentation and PMS plan methods for collection, assessment, complaints, trend reporting, communications, corrective actions, traceability, PMCF, and PMSR or PSUR outputs. - [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%5Fen?filename=md%5Fmdcg%5F2020%5F7%5Fguidance%5Fpmcf%5Fplan%5Ftemplate%5Fen.pdf&ref=sorena.io) - MDCG 2020-7 supports the PMCF evidence register by tying PMCF activities to clinical evaluation, risk management, technical documentation, and PMCF evaluation report timing. ## 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, PMS plan, PMS report, PSUR, vigilance, trend reporting, PMCF linkage, and Annex III PMS technical-documentation requirements. - Quote: "Post-market surveillance, vigilance and market surveillance" - [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%5Fen?filename=md%5Fmdcg%5F2020%5F7%5Fguidance%5Fpmcf%5Fplan%5Ftemplate%5Fen.pdf&ref=sorena.io) - MDCG guidance source for PMCF plan fields, PMCF objectives, PMCF activities, clinical evaluation and risk-management references, and PMCF evaluation report timing. - Quote: "Post-market clinical follow-up plan Template" - [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%5Fen?filename=mdcg%5F2022-21%5Fen.pdf&ref=sorena.io) - MDCG guidance source for PSUR scope, grouping, data collection periods, issuance timing, submission or availability, and class-based PSUR handling. - Quote: "Guidance on Periodic Safety Update Report" - [MDCG 2023-3 Rev.2 vigilance Q&A](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%5Fen?filename=mdcg%5F2023-3%5Fen.pdf&ref=sorena.io) - MDCG guidance source for incident and serious-incident concepts, complaint and PMS information sources, reportability uncertainty, trend reports, MIR reporting, and VGL-module context. - Quote: "vigilance terms and concepts" ## 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 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 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/post-market-surveillance-plan-template.md