--- title: "EU MDR vigilance reporting workflow" canonical_url: "https://www.sorena.io/artifacts/eu/medical-device-regulation/vigilance-reporting-workflow" source_url: "https://www.sorena.io/artifacts/eu/medical-device-regulation/vigilance-reporting-workflow" author: "Sorena AI" description: "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." published_at: "2026-05-09" updated_at: "2026-05-09" keywords: - "EU MDR vigilance reporting" - "serious incident" - "FSCA" - "FSN" - "trend reporting" - "EUDAMED" - "EU Medical Device Regulation" - "EU MDR" - "Regulation (EU) 2017/745" - "vigilance reporting" - "field safety corrective action" --- **[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 vigilance reporting workflow 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. *Workflow* *EU MDR* ## EU MDR vigilance reporting workflow Use this workflow when complaint, support, PMS, distributor, importer, healthcare-professional, user, patient, or authority information may involve a medical device incident on the Union market. The workflow separates intake, seriousness assessment, serious incident reporting, FSCA and FSN handling, trend reporting, EUDAMED routing, notified-body communication, CAPA, PMS, clinical evaluation updates, and records. EU MDR vigilance reporting starts when the manufacturer receives information about a possible issue with a device made available on the Union market. The working file should capture the product identifiers, event facts, patient or user outcome, causal assessment, reporting route, authority communication, corrective action decision, and the PMS records that need updating. ## 1. Intake and triage the vigilance signal Open a vigilance record as soon as the manufacturer receives information from complaints, technical support, PMS or PMCF activity, literature, registries, healthcare professionals, users, patients, importers, distributors, authorised representatives, or competent authorities. The first decision is not whether the report is convenient to complete; it is whether the information describes an incident with a device and whether serious-incident criteria can be excluded. - Record device name, Basic UDI-DI or UDI-DI where available, model, lot or serial number, software or firmware version, market status, country of occurrence, reporter type, date first received by the manufacturer's organisation, and whether any outsourced complaint handler or authorised representative received the information first. - Classify the issue type: malfunction or deterioration, use error due to ergonomic features, inadequacy in information supplied by the manufacturer, undesirable side-effect, or another device-related quality, performance, or safety signal. - Preserve the original complaint, returned device status, logs, images, service records, IFU or labelling version, and any clinical context needed to assess actual or potential harm. - If the information is not an incident, close the vigilance-reportability path only after documenting the rationale in the quality management system and routing the data into PMS, complaint, CAPA, supplier, or usability review as applicable. 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 source for incident, serious incident, FSCA, FSN, PMS, vigilance, and Article 87 to Article 92 reporting duties. - [MDCG 2022-7 - UDI system Q&A](https://health.ec.europa.eu/system/files/2022-05/mdcg_2022-7_en.pdf?ref=sorena.io) - Grounds the need to connect UDI data with vigilance records and to provide UDI-PI for individual devices involved in vigilance incidents. - [MDCG 2023-3 Rev.2 - vigilance terms and concepts 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) - Grounds the intake sources, incident-versus-serious-incident triage, uncertainty handling, manufacturer awareness date, FSCA examples, FSN handling, and EUDAMED vigilance-module caveat. ## 2. Decide whether the event is a serious incident Assess the actual and reasonably possible outcome, not only the outcome that happened in this case. Under the MDR, a serious incident is an incident that directly or indirectly led, might have led, or might lead to death, serious deterioration of health, or a serious public health threat. - Treat the case as reportable if death, temporary or permanent serious deterioration of health, or a serious public health threat occurred or could have occurred under less favourable circumstances. - Check whether an expected side-effect is clearly documented in product information, quantified in technical documentation, and subject to trend reporting; otherwise do not use expectedness as a shortcut to avoid Article 87 assessment. - When reportability is uncertain, submit within the applicable MDR timeframe rather than waiting for complete root-cause evidence. - If later evidence shows that a submitted case was not reportable, document the investigation conclusion and rationale instead of deleting the reporting history. 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 2 defines serious incident and Article 87 requires reporting despite uncertainty when an incident may be reportable. - [MDCG 2023-3 Rev.2 - vigilance terms and concepts 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) - Grounds the practical serious-incident assessment rule that potential outcomes under less favourable circumstances must be considered. ## 3. Apply MDR reporting timelines only after the reporting trigger is clear Use the MDR Article 87 clocks for serious incident reports. Start from manufacturer awareness and the point at which causal relationship is established or reasonably possible, or from awareness of the serious public health threat or serious incident where the specific Article 87 deadline applies. - General serious incident: report immediately after causal relationship is established or reasonably possible, and not later than 15 days after awareness of the incident. - Serious public health threat: report immediately and not later than 2 days after awareness of the threat. - Death or unanticipated serious deterioration in a person's state of health: report immediately after causal relationship is established or suspected, and not later than 10 days after awareness of the serious incident. - Incomplete information is not a reason to miss the clock; submit an initial report where necessary and follow with a complete report. - For recurring similar serious incidents, use periodic summary reporting only where the MDR conditions are met and the relevant competent authority has agreed the format, content, and frequency. 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 87 provides the 15-day, 2-day, and 10-day serious incident reporting limits and permits incomplete initial reports followed by complete reports. - [MDCG 2023-3 Rev.2 - vigilance terms and concepts 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) - Grounds manufacturer awareness date handling and the point that incomplete information does not justify delaying the initial MIR. ## 4. Route FSCA, FSN, trend reporting, and EUDAMED correctly Separate the regulatory outputs. A serious incident report, an FSCA report, a field safety notice, a trend report, a periodic summary report, and PMS or PSUR updates are not substitutes for each other. - Report any FSCA for devices made available on the Union market, including a third-country FSCA for the same device where the reason is not limited to the third-country device. - Except in urgent cases where immediate FSCA is needed, report the FSCA without undue delay before undertaking it. - Send an FSN without delay to users or customers affected by an FSCA; identify the device, relevant UDI, manufacturer SRN where issued, reason for the action, associated patient or user risks, and actions users must take. - Report trend signals when there is a statistically significant increase in frequency or severity of non-serious incidents or expected undesirable side-effects that could affect benefit-risk and lead or may lead to unacceptable risk. - Until the EUDAMED Post-market surveillance and Vigilance module becomes mandatory, continue using the applicable national vigilance reporting processes; after mandatory use, follow EUDAMED processes and the alternative data-exchange mechanisms for technical unavailability. 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 to 92 ground FSCA reporting, FSN content, trend reports, periodic summary reports, and the electronic system for vigilance and PMS. - [EUDAMED portal](https://webgate.ec.europa.eu/eudamed?ref=sorena.io) - Grounds the current EUDAMED module landscape and identifies the post-market surveillance and vigilance module as one of the six EUDAMED modules. - [Commission Implementing Regulation (EU) 2021/2078 on EUDAMED](https://eur-lex.europa.eu/eli/reg_impl/2021/2078?ref=sorena.io) - Grounds EUDAMED setup, maintenance, data exchange, and alternative mechanisms when the system is unavailable or malfunctioning. - [MDCG 2023-3 Rev.2 - vigilance terms and concepts 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) - Grounds the interim requirement to use national reporting processes until the EUDAMED Post-market surveillance and Vigilance module becomes mandatory. ## 5. Communicate with authorities, notified bodies, customers, and internal owners The workflow should make communication ownership explicit because MDR vigilance involves several audiences. The relevant competent authority depends on where the serious incident occurred or where the FSCA is being or will be undertaken; notified bodies receive access or information where the case relates to devices for which they issued certificates or where PMS, PSUR, certificate, or conformity-assessment follow-up requires it. - For serious incidents, identify the competent authority of the Member State where the incident occurred and keep the investigation, risk assessment, and follow-up action traceable to that authority file. - For FSCAs, identify every Member State where the action is being or will be undertaken and the Member State where the manufacturer has its registered place of business. - Coordinate with the notified body where the MDR, certificate conditions, PSUR review, clinical evaluation follow-up, or authority assessment makes the vigilance information relevant to certified devices. - For customers and users, control the FSN text, translations, issue date, recipient list, acknowledgement tracking, and effectiveness checks; the notice must not understate the risk. - Assign internal owners for regulatory reporting, medical or clinical assessment, complaint investigation, product engineering, quality/CAPA, supply chain, customer communication, legal review, and PMS or clinical evaluation updates. 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 89 grounds competent-authority evaluation, manufacturer cooperation, notified-body relevance, and FSN communication to users. - [MDCG 2023-3 Rev.2 - vigilance terms and concepts 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) - Grounds evaluating competent-authority routing for serious incidents, FSCAs, draft FSNs, and relevant notified-body information flow. ## 6. Close the loop through CAPA, PMS, clinical evaluation, and records Do not close a vigilance file at submission. MDR post-market surveillance requires active gathering, recording, and analysis of quality, performance, and safety data throughout the device lifetime, with conclusions feeding preventive and corrective actions and updates to technical documentation. - Link the vigilance case to CAPA where the investigation identifies a need for preventive action, corrective action, design change, supplier action, labelling update, software update, servicing instruction, recall, or other FSCA. - Update the PMS plan inputs, PMS report or PSUR, trend thresholds, risk management file, benefit-risk determination, IFU and labelling, design and manufacturing information, and technical documentation where the case changes the evidence base. - Update the clinical evaluation and PMCF planning where the incident, trend, FSCA, or user feedback affects clinical safety, performance, residual risk, undesirable side-effects, or the benefit-risk conclusion. - Maintain the audit trail: intake record, seriousness assessment, rationale for reportability or non-reportability, submitted MIR or national report, FSCA report, FSN draft and final versions, authority comments, customer distribution evidence, investigation reports, CAPA records, PMS and clinical evaluation updates, and final report to the competent authority where required. - Keep UDI and device-status data aligned with vigilance and PMS records so affected devices can be identified, recalled, monitored, or excluded from scope without relying on free-text descriptions. 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 to 86 ground PMS, PSUR, preventive and corrective actions, technical documentation updates, and clinical evaluation 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) - Grounds linking UDI data with vigilance records, trend reporting, PMS reports, MIR, and PSUR handling. *Recommended next step* *Placement: after workflow records section* ## Turn MDR vigilance events into reportable records Use Sorena to keep intake facts, seriousness assessment, reporting clocks, FSCA and FSN actions, EUDAMED caveats, CAPA links, PMS updates, and source citations together. - [Open the EU MDR Research Copilot](/solutions/research-copilot.md): Answer MDR vigilance, PMS, EUDAMED, and evidence questions with cited outputs. - [Talk through MDR implementation](/contact.md): Review your vigilance intake model, reportability decisions, records, and escalation process. ## 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 incident definitions, serious incident reporting, FSCA, FSN, trend reporting, PMS, PSUR, clinical evaluation updates, and the Article 92 electronic system. - Quote: "Reporting of serious incidents and field safety corrective actions" - [EUDAMED portal](https://webgate.ec.europa.eu/eudamed?ref=sorena.io) - EUDAMED source for the database purpose, module structure, and current module-use context relevant to vigilance routing caveats. - Quote: "EUDAMED is composed of six modules" - [Commission Implementing Regulation (EU) 2021/2078 on EUDAMED](https://eur-lex.europa.eu/eli/reg_impl/2021/2078?ref=sorena.io) - EUDAMED implementing source for setup, maintenance, data exchange, and fallback mechanisms when EUDAMED is technically unavailable. - Quote: "European Database on Medical Devices" - [MDCG 2022-7 - UDI system Q&A](https://health.ec.europa.eu/system/files/2022-05/mdcg_2022-7_en.pdf?ref=sorena.io) - UDI guidance source for linking UDI data to serious incident, FSCA, MIR, PSUR, trend reporting, and vigilance records. - Quote: "the UDI shall be used for reporting serious incidents" - [MDCG 2023-3 Rev.2 - vigilance terms and concepts 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 intake sources, seriousness assessment, manufacturer awareness date, uncertainty handling, MIR use, FSCA and FSN examples, evaluating competent-authority routing, and EUDAMED vigilance-module caveats. - Quote: "Questions and Answers on 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): 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 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): 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. - [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) | [Terms of Use](https://www.sorena.io/terms-of-use) | [DMCA](https://www.sorena.io/dmca) | [About Us](https://www.sorena.io/about-us) (c) 2026 Sorena AB (559573-7338). All rights reserved. Source: https://www.sorena.io/artifacts/eu/medical-device-regulation/vigilance-reporting-workflow