--- title: "EU MDR Annex II and III Technical Documentation" canonical_url: "https://www.sorena.io/artifacts/eu/medical-device-regulation/annex-ii-and-iii-technical-documents" source_url: "https://www.sorena.io/artifacts/eu/medical-device-regulation/annex-ii-and-iii-technical-documents" author: "Sorena AI" description: "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." published_at: "2026-05-09" updated_at: "2026-05-09" keywords: - "EU MDR Annex II" - "EU MDR Annex III" - "technical documentation" - "GSPR checklist" - "post-market surveillance" - "UDI" - "EUDAMED" - "EU Medical Device Regulation" - "EU MDR" - "Regulation (EU) 2017/745" - "Annex II technical documentation" - "Annex III PMS documentation" --- **[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 Annex II and III Technical Documentation 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. *Artifact Guide* *EU MDR* ## Annex II and Annex III Technical Documentation Annex II is the MDR technical file map for the device itself: description, specification, design and manufacturing information, GSPR demonstration, benefit-risk and risk management, verification, validation, clinical evaluation, and PMCF evidence. Annex III is the post-market surveillance file: the PMS plan, PMS report or PSUR, complaint and incident data, trend methods, CAPA links, and evidence that updates the risk and clinical files. Use this page as an MDR technical documentation index. It separates the Annex II pre-market technical file from the Annex III post-market surveillance file, then names the records that should cross-reference each other so a reviewer can trace the device claim, test evidence, clinical evidence, risk controls, PMS signals, UDI records, and EUDAMED submissions. ## Annex II file structure Start the Annex II file with a device description that can identify exactly what is being assessed. The MDR calls for the product or trade name, intended purpose, intended users, Basic UDI-DI or another unambiguous reference until UDI-based identification applies, intended patient population, medical conditions, indications, contraindications, warnings, operating principles, device qualification rationale, risk class, classification-rule justification, novel features, accessories, variants, configurations, key functional elements, materials, and technical specifications. Keep design and manufacturing records close to that description. Annex II expects information that lets the design stages be understood, complete manufacturing-process and validation information, continuous monitoring and final product testing, and identification of the sites, suppliers, and subcontractors where design or manufacturing activities are performed. - Index each model, variant, configuration, accessory, and software version against the same intended purpose and classification rationale used in the clinical evaluation and risk file. - Keep label, packaging, and instructions-for-use sets by market language because Annex II includes information supplied by the manufacturer. - Use controlled document identifiers for drawings, bills of material, software architecture, manufacturing validation, supplier controls, final release tests, and change records. Sources for this answer: - [Regulation (EU) 2017/745 on medical devices](https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32017R0745&locale=en&ref=sorena.io) - Annex II defines the technical documentation file structure, including device description, specifications, design and manufacturing information, GSPR demonstration, risk, and verification/validation evidence. - [European Commission UDI/device registration](https://health.ec.europa.eu/medical-devices-eudamed/udidevice-registration_en?ref=sorena.io) - Commission EUDAMED material supports keeping Basic UDI-DI, UDI-DI, UDI/device data set, and EMDN registration references aligned with the device-description index. ## GSPR, benefit-risk, risk management, and validation The GSPR checklist should not be a yes/no table without evidence. Annex II requires the applicable General Safety and Performance Requirements from Annex I, an explanation for non-applicable requirements, the method used to demonstrate conformity, any harmonised standards, common specifications, or other solutions applied, and the exact controlled documents that prove conformity. The same file should link benefit-risk analysis, risk management outputs, and product verification and validation. Verification and validation should include results and critical analyses of tests or studies used to show MDR conformity, including pre-clinical evidence such as engineering, laboratory, simulated-use, animal, biocompatibility, characterization, electrical safety, EMC, software verification and validation, stability, performance, and safety evidence where relevant. - For each GSPR row, record applicability, method, standard or common specification, controlled evidence ID, location in the file, reviewer, and open gaps. - Tie residual risks to risk controls, instructions for use, clinical evaluation conclusions, PMS indicators, and PMCF questions. - Where no new testing is performed, keep the rationale and the earlier evidence being relied on, rather than leaving the test section blank. Sources for this answer: - [Regulation (EU) 2017/745 on medical devices](https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32017R0745&locale=en&ref=sorena.io) - Annex II sections 4 to 6 ground the GSPR checklist, benefit-risk and risk-management records, and verification and validation evidence expected in the technical documentation. - [European Commission harmonised standards overview](https://single-market-economy.ec.europa.eu/single-market/goods/european-standards/harmonised-standards_en?ref=sorena.io) - Commission guidance supports using cited harmonised standards as part of the conformity demonstration where the standard is applicable and correctly identified. *Recommended next step* *Placement: after evidence section* ## Turn the Annex II and III index into an evidence matrix Use the MDR technical-file map to connect device claims, GSPR evidence, risk controls, validation records, clinical evaluation, PMS outputs, UDI data, and EUDAMED submissions. - [Open Research Copilot](/solutions/research-copilot.md): Map MDR source requirements to technical-file evidence and review questions. - [Talk through implementation](/contact.md): Review Annex II and III structure, evidence gaps, and PMS traceability before release or notified-body review. ## Clinical evaluation and PMCF links Annex II places the clinical evaluation plan, clinical evaluation report, report updates, PMCF plan, and PMCF evaluation report in the technical documentation. The clinical file should therefore cite the exact device description, intended purpose, risk controls, state-of-the-art position, and claims being supported. The PMCF plan should not sit apart from the file. MDR Annex XIV treats PMCF as a continuous process that updates clinical evaluation through proactive clinical-data collection, confirms safety and performance, checks continued acceptability of identified risks, detects emerging risks, and documents results in a PMCF evaluation report that feeds clinical evaluation and risk management. - Use the same intended purpose, patient population, indications, contraindications, warnings, and device variants in the Annex II description, clinical evaluation, and PMCF plan. - For each PMCF activity, define whether it confirms safety, confirms performance, identifies side effects, monitors contraindications, detects emerging risks, reassesses benefit-risk, or checks misuse and off-label use. - Keep PMCF output links back to the clinical evaluation, risk management file, PMS plan, PSUR or PMS report, and GSPR evidence affected by the findings. Sources for this answer: - [Regulation (EU) 2017/745 on medical devices](https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32017R0745&locale=en&ref=sorena.io) - Annex II section 6.1 and Annex XIV ground the clinical evaluation, clinical evaluation updates, PMCF plan, and PMCF evaluation-report references in the technical documentation. - [European Commission UDI/device registration](https://health.ec.europa.eu/medical-devices-eudamed/udidevice-registration_en?ref=sorena.io) - Commission EUDAMED material supports cross-referencing clinical and PMCF device identifiers to UDI/device registration data where those identifiers are used in market records. ## Annex III PMS file Annex III is the technical documentation on post-market surveillance. It should contain the PMS plan drawn up under Article 84 and the PMS report for class I devices or PSUR for class IIa, IIb, and III devices. The PMS plan must show how the manufacturer collects and uses information from serious incidents, PSURs, field safety corrective actions, non-serious incidents, undesirable side effects, trend reporting, literature, databases, registries, user feedback, distributor and importer feedback, complaints, and public information about similar devices. The PMS plan also needs methods, not just inputs. Annex III calls for proactive and systematic collection, methods to assess data, indicators and thresholds for continuous benefit-risk and risk-management reassessment, complaint investigation methods, trend-report protocols, authority and notified-body communication methods, procedures for Articles 83, 84, and 86, corrective-action procedures, device-tracing tools, and a PMCF plan or a justification that PMCF is not applicable. - Keep a PMS data inventory that names the data source, owner, collection frequency, analysis method, threshold, escalation route, and affected technical-file sections. - For class I devices, keep the PMS report with results, conclusions, rationale, and preventive or corrective actions; for class IIa, IIb, and III devices, keep the PSUR instead. - Use PMS outputs to update clinical evaluation, risk management, GSPR evidence, labels, IFU, CAPA records, vigilance decisions, and design-change records. Sources for this answer: - [Regulation (EU) 2017/745 on medical devices](https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32017R0745&locale=en&ref=sorena.io) - Articles 83 to 86 and Annex III ground the PMS system, PMS plan, PMS report, PSUR, data sources, indicators, trend methods, and corrective-action links. - [European Commission UDI/device registration](https://health.ec.europa.eu/medical-devices-eudamed/udidevice-registration_en?ref=sorena.io) - Commission EUDAMED material supports keeping UDI/device submissions and EUDAMED records traceable to PMS, PSUR, vigilance, and device-identification evidence. ## UDI, EUDAMED, and traceability records Annex II expects the Basic UDI-DI when device identification is based on the UDI system, or another unambiguous product reference until then. The UDI record should align with the product name, model, version, sterile status, single-use status, quantity per package, warnings, contraindications, and software identification used in labels, declarations, certificates, EUDAMED entries, and technical documentation. Commission EUDAMED material states that MDR and IVDR introduce a UDI-based device identification system for traceability and that manufacturers must submit UDI/device information in EUDAMED for devices placed on the EU market. The UDI/device module information page also identifies Basic UDI-DI and UDI-DI concepts, UDI/device data sets, EMDN use, and UDI helpdesk material as implementation references. - Record Basic UDI-DI, UDI-DI, UDI-PI rules, issuing entity, packaging levels, label placement, software UDI handling, and any change that triggers a new UDI-DI. - Cross-check UDI records against Annex II device variants, Annex IV declaration of conformity, certificates, EUDAMED registration data, labels, IFU, and PMS traceability needs. - Keep EUDAMED submission confirmations, validation errors, update records, and EMDN choices with the controlled technical-file index. Sources for this answer: - [European Commission UDI/device registration](https://health.ec.europa.eu/medical-devices-eudamed/udidevice-registration_en?ref=sorena.io) - Commission EUDAMED material supports the UDI/device registration and EMDN references for manufacturers submitting device information in EUDAMED. - [MDCG 2022-7 UDI system Q&A](https://health.ec.europa.eu/system/files/2022-05/mdcg_2022-7_en.pdf?ref=sorena.io) - MDCG 2022-7 supports UDI assignment, UDI carrier, Basic UDI-DI, UDI-DI change, software UDI, and economic-operator traceability points. ## Evidence records to keep audit-ready The practical output is a controlled evidence matrix, not a narrative policy. Each row should identify the claim or requirement, device version or configuration, document owner, source requirement, evidence document, file location, approval status, open questions, and the trigger that will reopen the row. Use release gates that check whether Annex II and Annex III still agree with each other. A design change, supplier change, software release, new complaint trend, PMCF finding, new safety signal, UDI data change, EUDAMED update, new or revised standard, or notified-body question can affect the device description, GSPR checklist, clinical evaluation, risk management, PMS plan, PSUR, labels, or declaration of conformity. - Core Annex II evidence: device description, intended purpose, Basic UDI-DI or product code, classification rationale, design history, manufacturing process validation, supplier and site list, GSPR matrix, risk file, verification and validation reports, clinical evaluation, PMCF records, label and IFU sets, and declaration of conformity references. - Core Annex III evidence: PMS plan, PMS report or PSUR, complaint and feedback logs, non-serious incident records, serious-incident and FSCA links, trend analyses, literature and registry searches, similar-device monitoring, CAPA records, PMS-to-risk updates, and PMS-to-clinical updates. - Core traceability evidence: UDI assignment decisions, label carrier checks, packaging-level records, EUDAMED registration data, EMDN selection, submission confirmations, and change records for data elements that require update or new UDI-DI assessment. Sources for this answer: - [Regulation (EU) 2017/745 on medical devices](https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32017R0745&locale=en&ref=sorena.io) - The MDR grounds the evidence matrix because Annex II and Annex III require searchable technical documentation, controlled evidence references, PMS plans, and PMS reports or PSURs. - [European Commission UDI/device registration](https://health.ec.europa.eu/medical-devices-eudamed/udidevice-registration_en?ref=sorena.io) - The EUDAMED UDI/device page supports keeping UDI/device registration, data-set, EMDN, and submission records with the technical-file traceability evidence. ## Primary sources - [Regulation (EU) 2017/745 on medical devices](https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32017R0745&locale=en&ref=sorena.io) - Primary legal source for Annex II technical documentation, Annex III PMS documentation, Articles 83 to 86, Annex VI UDI concepts, Annex XIV clinical evaluation and PMCF, and Annex IV declaration links. - Quote: "clear, organised, readily searchable and unambiguous" - [European Commission UDI/device registration](https://health.ec.europa.eu/medical-devices-eudamed/udidevice-registration_en?ref=sorena.io) - Grounding source for UDI/device registration, EUDAMED submission, Basic UDI-DI and UDI-DI implementation references, UDI/device data sets, and EMDN registration context. - Quote: "device identification system based on a unique device identifier" - [MDCG 2022-7 UDI system Q&A](https://health.ec.europa.eu/system/files/2022-05/mdcg_2022-7_en.pdf?ref=sorena.io) - Grounding source for UDI assignment, UDI carrier placement, Basic UDI-DI, new UDI-DI triggers, software UDI, and UDI obligations for economic operators. - Quote: "Unique Device Identification system" - [European Commission harmonised standards overview](https://single-market-economy.ec.europa.eu/single-market/goods/european-standards/harmonised-standards_en?ref=sorena.io) - Grounding source for harmonised-standards context where the GSPR evidence matrix cites standards as a conformity demonstration method. - Quote: "Harmonised standards are European standards" ## 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 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. - [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) | [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). 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