--- title: "EU MDR Annex VIII Classification Guide" canonical_url: "https://www.sorena.io/artifacts/eu/medical-device-regulation/annex-viii-classification" source_url: "https://www.sorena.io/artifacts/eu/medical-device-regulation/annex-viii-classification" author: "Sorena AI" description: "Classify EU MDR medical devices under Annex VIII using intended purpose, duration, invasiveness, active device and software rules, and conformity assessment impact." published_at: "2026-05-09" updated_at: "2026-05-09" keywords: - "EU MDR Annex VIII" - "medical device classification" - "MDR Rule 11" - "medical device software classification" - "MDR conformity assessment" - "EU Medical Device Regulation" - "EU MDR" - "Regulation (EU) 2017/745" - "Annex VIII classification" - "Rule 11 software" - "conformity assessment" --- **[SORENA](https://www.sorena.io/)** - AI-Powered GRC Platform [Home](https://www.sorena.io/) | [Solutions](https://www.sorena.io/solutions) | [Artifacts](https://www.sorena.io/artifacts) | [About Us](https://www.sorena.io/about-us) | [Contact](https://www.sorena.io/contact) | [Portal](https://app.sorena.io) --- # EU MDR Annex VIII Classification Guide Classify EU MDR medical devices under Annex VIII using intended purpose, duration, invasiveness, active device and software rules, and conformity assessment impact. *Artifact Guide* *EU* ## EU MDR Annex VIII Classification Annex VIII is the MDR rule set for assigning a device to class I, IIa, IIb, or III by looking at intended purpose and inherent risk. Use this page to document the classification rationale, identify when software or active-device rules change the class, and connect the class to the conformity assessment route. EU MDR Article 51 divides devices into classes I, IIa, IIb, and III by intended purpose and inherent risks, with classification carried out under Annex VIII. A useful classification file should therefore show the product's intended purpose, relevant duration and invasiveness facts, active-device or software analysis, the rule that produced the highest class, and the resulting conformity assessment route. ## Start with intended purpose and device facts Annex VIII classification is governed by the manufacturer's intended purpose. Do not start with a market category, product family, or competitor class; start with the actual claims, instructions for use, clinical context, target users, patient population, body contact, and whether the item is a device, an accessory, an Annex XVI product, or software. Record the facts that Annex VIII uses: whether the device is non-invasive, invasive through a body orifice, surgically invasive, implantable, active, or software; whether it contacts injured skin or mucous membrane; the relevant body site; whether substances are absorbed or locally dispersed; and the duration of continuous use. - Classify each device and accessory in its own right when products are used together. - Use transient, short-term, and long-term duration based on continuous use, including immediate replacement with the same type of device. - If multiple rules or sub-rules apply to the same intended purpose, keep the strictest rule that results in the higher classification. - For each conclusion, cite the exact Annex VIII rule and the device fact that makes the rule apply. 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 51 and Annex VIII establish the four MDR classes, the intended-purpose basis for classification, separate classification of accessories, continuous-use handling, and the higher-class rule where multiple rules apply. - [MDCG 2021-24 guidance on classification of medical devices](https://health.ec.europa.eu/system/files/2021-10/mdcg_2021-24_en_0.pdf?ref=sorena.io) - Explains practical classification criteria including duration, invasiveness, active devices, intended purpose, and documentation of the classification rationale. ## Apply non-invasive, invasive, implantable, and active-device rules For non-invasive devices, Annex VIII starts from class I unless a more specific rule applies, such as channeling or storing blood or body liquids, modifying biological or chemical composition, direct contact with human cells or embryos, or contact with injured skin or mucous membrane. For invasive and implantable devices, duration and route into the body often decide the rule. Body-orifice devices are treated separately from surgically invasive devices, and implantable or long-term surgically invasive devices generally start higher before exceptions and class III triggers are considered. For active devices, document the energy or substance pathway. Annex VIII contains separate rules for active therapeutic devices, active diagnostic and monitoring devices, software, devices that administer or remove medicinal products or body liquids, and residual active devices. - Capture duration as a classification fact, not a project assumption: less than 60 minutes, 60 minutes to 30 days, or more than 30 days. - For invasive devices, record body orifice versus surgically created access, central circulatory or central nervous system contact, absorption, biological effect, medicinal-product administration, and implant status. - For active therapeutic devices, assess whether energy exchange may be potentially hazardous based on the energy nature, density, and application site. - For active diagnosis or monitoring devices, assess direct diagnosis, vital physiological monitoring, and immediate-danger clinical situations before assigning class IIa or IIb. Sources for this answer: - [Regulation (EU) 2017/745 on medical devices](https://eur-lex.europa.eu/eli/reg/2017/745/oj?ref=sorena.io) - Annex VIII Rules 1 to 13 provide the non-invasive, invasive, implantable, active therapeutic, active diagnostic and monitoring, software, substance administration, and other active-device classification rules. - [MDCG 2021-24 guidance on classification of medical devices](https://health.ec.europa.eu/system/files/2021-10/mdcg_2021-24_en_0.pdf?ref=sorena.io) - Provides practical explanations for duration of use, continuous use, invasiveness, surgically invasive devices, implantable devices, and active medical devices. ## Classify software with Rule 11 and related active-device rules Software needs two separate checks. First, decide whether it is medical device software: MDCG 2019-11 states that software must have a medical purpose on its own to qualify as medical device software, although software that drives or influences a hardware medical device can still affect the hardware device's classification. If the software is medical device software, Rule 11 classifies software that provides information used for diagnostic or therapeutic decisions as class IIa, with escalation to class IIb or III when the decision impact could involve serious deterioration, surgical intervention, death, or irreversible deterioration. Software intended to monitor physiological processes is class IIa unless it monitors vital physiological parameters where variations could create immediate danger, in which case it is class IIb. Other software is class I unless another Annex VIII rule applies. Do not treat every digital health workflow as Rule 11 software. MDCG 2019-11 distinguishes simple storage, archiving, communication, search, and non-medical operational software from software that processes, analyses, creates, or modifies medical information for a medical intended purpose. - Record whether the software has its own medical purpose, drives or influences another device, or only stores, transfers, displays, or searches information. - For Rule 11(a), document the healthcare decision, the significance of the information, the patient condition, and the foreseeable impact of an incorrect decision. - For Rule 11(b), document whether monitoring is for physiological processes only or for vital physiological parameters in a context where variation could cause immediate danger. - For software that drives or influences a hardware device, apply Annex VIII implementing rule 3.3 and check whether another active-device rule produces the class. Sources for this answer: - [Regulation (EU) 2017/745 on medical devices](https://eur-lex.europa.eu/eli/reg/2017/745/oj?ref=sorena.io) - Annex VIII implementing rule 3.3 and Rule 11 set the MDR classification basis for independent software and software that drives or influences another device. - [MDCG 2019-11 guidance on qualification and classification of software](https://health.ec.europa.eu/system/files/2020-09/md_mdcg_2019_11_guidance_en_0.pdf?ref=sorena.io) - Guidance for deciding whether software qualifies as medical device software and how Rule 11 applies to diagnosis, therapy, monitoring, and software location or interconnection. - [MDCG 2021-24 guidance on classification of medical devices](https://health.ec.europa.eu/system/files/2021-10/mdcg_2021-24_en_0.pdf?ref=sorena.io) - Summarises Rule 11 examples and practical issues, including intended population, context of use, software information, and possible decisions. *Recommended next step* *Placement: after classification evidence section* ## Review an MDR classification rationale before route selection Check intended purpose, Annex VIII rule selection, software classification, notified body involvement, and the evidence package before locking the conformity assessment plan. - [Open Research Copilot](/solutions/research-copilot.md): Turn MDR classification questions into cited rationale drafts and reviewer-ready issue lists. - [Talk through implementation](/contact.md): Review your intended purpose, Rule 11 analysis, conformity route, and technical documentation evidence. ## Connect the class to conformity assessment and notified body route The class is not just a label. Article 52 links class III, IIb, IIa, and certain class I devices to different conformity assessment procedures in Annexes IX to XI. MDCG 2021-24 explains the practical result: all devices need MDR obligations such as GSPR compliance, technical documentation, post-market surveillance documentation, vigilance, CE marking where applicable, UDI, and registration, but notified body involvement increases with the device class. Class I devices generally use manufacturer declaration after technical documentation is drawn up, but sterile class I, measuring class I, and reusable surgical instruments have limited notified body involvement for those specific aspects. Class IIa, IIb, and III devices require notified body assessment under the applicable Article 52 route, with representative technical documentation sampling for many class IIa and IIb devices and more intensive assessment for higher-risk classes. When a notified body is required, record the chosen conformity assessment route, the device group or category used for any representative sampling, and whether special MDR procedures apply, such as class III custom-made implantable provisions or clinical evaluation consultation for class III implantable devices and class IIb active devices that administer or remove medicinal products. - Add the resulting route to the classification memo: Article 52 paragraph, Annex IX/X/XI option, and notified body scope needed. - For class I sterile, measuring, or reusable surgical instruments, document the limited notified body aspects instead of describing the whole device as fully notified-body certified. - For class IIa and IIb devices, identify the representative device category or generic device group used for technical documentation assessment. - For high-risk routes, flag added expert-panel or consultation procedures only where the MDR provision applies to the specific device type. 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 52 specifies conformity assessment routes by device class and limits notified body involvement for class I sterile, measuring, and reusable surgical instruments. - [MDCG 2021-24 guidance on classification of medical devices](https://health.ec.europa.eu/system/files/2021-10/mdcg_2021-24_en_0.pdf?ref=sorena.io) - Explains how device class affects conformity assessment, clinical evaluation, technical documentation, PMS, traceability, and instructions for use. - [European Commission - notified bodies for medical devices](https://health.ec.europa.eu/medical-devices-topics-interest/notified-bodies-medical-devices_en?ref=sorena.io) - Commission source explaining that notified bodies assess conformity before market placement where third-party intervention is required and that designated bodies are published in NANDO. ## Evidence to keep in the classification rationale The classification rationale should be reproducible by a reviewer who has not followed the product history. It should show the claims and use context assessed, the Annex VIII rules considered, the rule selected, the higher-class resolution where rules overlap, and the conformity assessment consequences. Keep the classification memo with the technical documentation because MDCG 2021-24 links the technical documentation to the device risk class and the justification for the Annex VIII rule applied. - Intended purpose extract from label, instructions for use, product specification, clinical claims, and promotional claims reviewed. - Device fact table covering duration, invasiveness, body site, implant status, active-device status, software function, target population, users, and clinical context. - Rule-by-rule analysis showing included, excluded, and escalated rules, with the final highest applicable class. - Software appendix, where relevant, covering MDSW qualification, Rule 11 decision impact, vital-parameter monitoring, and whether the software drives or influences a hardware device. - Conformity assessment route note showing Article 52 paragraph, selected Annex IX/X/XI route, notified body involvement, and any representative technical documentation sampling logic. - Change triggers for reclassification review, including new or changed intended purpose, clinical indication, target population, software function, hardware integration, body-contact duration, invasive route, energy delivery, substance absorption, or device combination. Sources for this answer: - [Regulation (EU) 2017/745 on medical devices](https://eur-lex.europa.eu/eli/reg/2017/745/oj?ref=sorena.io) - Supports the need to base classification on intended purpose, apply Annex VIII rules, and perform conformity assessment before placing devices on the market. - [MDCG 2021-24 guidance on classification of medical devices](https://health.ec.europa.eu/system/files/2021-10/mdcg_2021-24_en_0.pdf?ref=sorena.io) - Grounds the evidence expectation that technical documentation should include the risk class and the justification for the applied Annex VIII classification rules. ## Primary sources - [Regulation (EU) 2017/745 on medical devices](https://eur-lex.europa.eu/eli/reg/2017/745/oj?ref=sorena.io) - Primary MDR legal source for Article 51 classification, Article 52 conformity assessment, Annex VIII implementing rules, classification rules, and software Rule 11. - Quote: "Devices shall be divided into classes I, IIa, IIb and III" - [MDCG 2021-24 guidance on classification of medical devices](https://health.ec.europa.eu/system/files/2021-10/mdcg_2021-24_en_0.pdf?ref=sorena.io) - MDCG guidance used for practical classification criteria, class impact on conformity assessment, technical documentation evidence, and Rule 11 interpretation notes. - Quote: "The classification of medical devices in use by the EU medical device legislation is a risk-based system." - [MDCG 2019-11 guidance on qualification and classification of software](https://health.ec.europa.eu/system/files/2020-09/md_mdcg_2019_11_guidance_en_0.pdf?ref=sorena.io) - MDCG guidance used for medical device software qualification, Rule 11 classification, software driving or influencing hardware, and examples of non-device software functions. - Quote: "Medical device software is software that is intended to be used, alone or in combination" - [European Commission - notified bodies for medical devices](https://health.ec.europa.eu/medical-devices-topics-interest/notified-bodies-medical-devices_en?ref=sorena.io) - Commission source used for the role of notified bodies in third-party conformity assessment and NANDO publication context. - Quote: "when a third-party intervention is required" ## 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 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. - 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