--- title: "EU MDR qualification and borderline products" canonical_url: "https://www.sorena.io/artifacts/eu/medical-device-regulation/qualification-and-borderline-products" source_url: "https://www.sorena.io/artifacts/eu/medical-device-regulation/qualification-and-borderline-products" author: "Sorena AI" description: "EU MDR qualification guide for medical purpose claims, accessories, software, Annex XVI products, and borderline routes to classification and conformity assessment." published_at: "2026-05-09" updated_at: "2026-05-09" keywords: - "EU MDR qualification" - "borderline medical devices" - "medical device software" - "Annex XVI products" - "MDR intended purpose" - "EU Medical Device Regulation" - "EU MDR" - "Regulation (EU) 2017/745" - "qualification" - "borderline products" - "Annex XVI" --- **[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 qualification and borderline products EU MDR qualification guide for medical purpose claims, accessories, software, Annex XVI products, and borderline routes to classification and conformity assessment. *Artifact Guide* *EU MDR* ## EU MDR qualification and borderline products Qualification starts with the manufacturer's intended purpose: the MDR definition covers instruments, software, implants, reagents, materials, and other articles intended for specific medical purposes in humans. Use this page to separate medical devices, accessories, medical device software, Annex XVI no-medical-purpose products, and adjacent medicinal-product or IVD questions before choosing the classification and conformity route. An EU MDR qualification file should answer one narrow question before classification begins: does the product fall inside Regulation (EU) 2017/745 as a medical device, accessory, device-related software, or Annex XVI product, or does an adjacent regime drive the route? ## Start with the intended purpose evidence The MDR definition of a medical device turns on the manufacturer's intended use for humans and the specific medical purpose claimed. Check the label, instructions for use, promotional and sales statements, product specifications, clinical evaluation plan, website claims, sales training, and release notes before relying on an internal label such as wellness, cosmetic, analytics, platform, or accessory. A product points toward MDR qualification when the intended purpose is diagnosis, prevention, monitoring, prediction, prognosis, treatment, or alleviation of disease; diagnosis, monitoring, treatment, alleviation, or compensation for injury or disability; investigation, replacement, or modification of anatomy or a physiological or pathological process or state; or information from in vitro examination of human specimens. The principal intended action must not be pharmacological, immunological, or metabolic, although those means may assist the device. - Record the exact claim text and where it appears: label, IFU, app store listing, website, demo script, quotation, clinical evaluation, or sales material. - Separate product identity from use case: the same technical platform can have MDR and non-MDR modules if some functions have a medical purpose and others do not. - Treat intended-purpose changes as a new qualification trigger before release, because they can change both MDR scope and later classification. Sources for this answer: - [Regulation (EU) 2017/745 on medical devices](https://eur-lex.europa.eu/eli/reg/2017/745/oj?ref=sorena.io) - Defines medical device and intended purpose, including reliance on labels, instructions for use, promotional or sales materials, and clinical evaluation. ## Separate device, accessory, software, and Annex XVI routes If the product is not itself a medical device, test whether it is an accessory. Under the MDR, an accessory is not itself a medical device but is intended to be used with one or more particular medical devices to enable their intended purpose or directly assist their medical functionality. That means cables, controllers, consumables, connectors, apps, and service components need a specific device-function link, not just a general healthcare customer base. For software, apply the MDCG software qualification steps. Software that only stores, archives, communicates, losslessly compresses, or performs simple search is not qualified on that basis alone. Software that acts on data for the benefit of individual patients, drives or influences a hardware device, functions as an accessory, or is an Annex XVI product can fall into the medical devices framework and then needs classification. Annex XVI products are different: they are listed product groups without an intended medical purpose that the MDR brings in once common specifications apply. Examples grounded in the common specifications include non-corrective contact lenses, products introduced into the body to modify anatomy, dermal fillers, adipose-tissue reduction equipment, high-intensity optical radiation equipment for skin treatment, and non-invasive brain-stimulation equipment. If the same product has both medical and non-medical purposes, keep both requirement sets in the file. - Accessory evidence: identify the particular device, intended combined use, and the function the article enables or directly assists. - Software evidence: map whether the software acts on data, benefits individual patients, drives or influences a device, or creates information from IVD-only data. - Annex XVI evidence: name the listed product group, applicable common specification, risk-management record, and any clinical-evaluation evidence used to show safety. Sources for this answer: - [Regulation (EU) 2017/745 on medical devices](https://eur-lex.europa.eu/eli/reg/2017/745/oj?ref=sorena.io) - Defines accessories, treats software as an active device, and brings Annex XVI products within MDR scope when common specifications apply. - [MDCG 2019-11 rev.1 - qualification and classification of software](https://health.ec.europa.eu/document/download/b45335c5-1679-4c71-a91c-fc7a4d37f12b_en?filename=mdcg_2019_11_en.pdf&ref=sorena.io) - MDCG guidance source for deciding whether software is medical device software, drives or influences a device, or falls on the MDR or IVDR side. - [Commission Implementing Regulation (EU) 2022/2346 on Annex XVI common specifications](https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A32022R2346&ref=sorena.io) - Sets common specifications for Annex XVI product groups without an intended medical purpose, including risk-management and information-supplied requirements. *Recommended next step for EU MDR qualification* *Placement: after implementation section* ## Turn the qualification answer into a release gate Use the MDR qualification record to control claims, labels, software functions, Annex XVI assumptions, classification handoff, and conformity-assessment planning before market release. - [Open Research Copilot](/solutions/research-copilot.md): Answer EU MDR scope, qualification, and source questions with cited outputs. - [Talk through implementation](/contact.md): Review your intended-purpose evidence, borderline analysis, classification handoff, and release controls. ## Handle borderline questions without collapsing regimes Borderline files should explain why the MDR route, another EU route, or an escalation path applies. The MDR expressly excludes IVDs covered by Regulation (EU) 2017/746 and medicinal products covered by Directive 2001/83/EC, with principal mode of action central to the medicinal-product boundary. Where a device incorporates an IVD part, MDR governs the device while IVDR requirements apply to the IVD part. For software using IVD and medical-device data, MDCG 2019-11 uses the significance of the data sources for the intended purpose to decide whether the software belongs under MDR or IVDR. If the intended purpose is substantially driven by IVD data sources, the IVDR route is indicated; if substantially driven by medical-device data sources, the MDR route is indicated. Do not use GPSR, cosmetics, machinery, or general product-safety labels as shortcuts in an MDR qualification file unless the cited source supports the boundary. For this artifact, the grounded boundaries are MDR, accessory, software, Annex XVI, IVD, and medicinal-product boundaries. - Write a one-paragraph boundary conclusion for each adjacent regime considered and cite the exact MDR or MDCG basis. - Escalate to regulatory or notified-body review when the principal mode of action, software data source weighting, Annex XVI product group, or combined medical and non-medical purpose is unresolved. - Keep unsupported national penalty details, invented deadlines, and generic product-law statements out of the qualification record. Sources for this answer: - [Regulation (EU) 2017/745 on medical devices](https://eur-lex.europa.eu/eli/reg/2017/745/oj?ref=sorena.io) - Grounds the IVD and medicinal-product boundary, including the principal-mode-of-action test for medicinal products and treatment of incorporated IVD parts. - [European Commission guidance index - borderline and classification](https://health.ec.europa.eu/medical-devices-sector/new-regulations/guidance-mdcg-endorsed-documents-and-other-guidance_en?ref=sorena.io) - Commission guidance index listing the MDR/IVDR borderline manual, medicinal-product borderline guidance, Helsinki procedure, Annex XVI qualification guidance, and classification guidance. - [MDCG 2019-11 rev.1 - qualification and classification of software](https://health.ec.europa.eu/document/download/b45335c5-1679-4c71-a91c-fc7a4d37f12b_en?filename=mdcg_2019_11_en.pdf&ref=sorena.io) - Supports the MDR-versus-IVDR software boundary when software uses IVD data, medical-device data, or both. ## Escalate qualification into classification and conformity assessment A yes-scope answer is not enough for market release. Once the file concludes that the product is an MDR device, accessory, MDR medical device software, or Annex XVI product, route it into MDR classification, technical documentation, clinical evaluation or safety evidence, and conformity assessment planning. For software, MDCG 2019-11 points from qualification into Annex VIII classification. Software that drives or influences another device falls in the same class as that device; independent software is classified in its own right; and if several rules or sub-rules apply, the higher classification applies. Rule 11 is the central software rule for information used for diagnostic or therapeutic decisions and monitoring physiological processes. For Annex XVI products, the implementing regulation requires documented risk-management responsibilities, criteria, records, lifecycle updates, and information supplied with the product. Information for a non-medical purpose should not carry clinical-benefit claims; mixed medical and non-medical products need the claims separated. - Minimum output: product identity, intended-purpose evidence, qualification conclusion, adjacent-regime analysis, unresolved assumptions, and approval owner. - Classification handoff: applicable Annex VIII rule or software rule, rationale for strictest applicable rule, and whether notified-body involvement is expected. - Conformity handoff: technical documentation owner, clinical or safety evidence owner, label and IFU change owner, and release gate that blocks unsupported claim changes. Sources for this answer: - [MDCG 2019-11 rev.1 - qualification and classification of software](https://health.ec.europa.eu/document/download/b45335c5-1679-4c71-a91c-fc7a4d37f12b_en?filename=mdcg_2019_11_en.pdf&ref=sorena.io) - Explains software classification after qualification, including same-class treatment for software driving or influencing a device and Rule 11 considerations. - [MDCG 2021-24 - guidance on classification of medical devices](https://health.ec.europa.eu/medical-devices-sector/new-regulations/guidance-mdcg-endorsed-documents-and-other-guidance_en/document/download/cbb19821-a517-4e13-bf87-fdc6ddd1782e_en?filename=mdcg_2021-24_en.pdf&ref=sorena.io) - MDCG classification guidance listed in the MDR grounding folder for moving qualified MDR devices into the correct classification analysis. - [Commission Implementing Regulation (EU) 2022/2346 on Annex XVI common specifications](https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A32022R2346&ref=sorena.io) - Supports the Annex XVI handoff into documented risk management, lifecycle updates, information supplied, and non-medical claim controls. ## 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 medical device, accessory, intended purpose, Annex XVI, IVD boundary, medicinal-product boundary, and conformity assessment escalation. - Quote: "Subject matter and scope" - [European Commission guidance index - MDCG endorsed documents and other guidance](https://health.ec.europa.eu/medical-devices-sector/new-regulations/guidance-mdcg-endorsed-documents-and-other-guidance_en?ref=sorena.io) - Grounding source listing current Annex XVI, borderline, medicinal-product boundary, software, and classification guidance documents. - Quote: "MDCG endorsed documents" - [MDCG 2019-11 rev.1 - qualification and classification of software](https://health.ec.europa.eu/document/download/b45335c5-1679-4c71-a91c-fc7a4d37f12b_en?filename=mdcg_2019_11_en.pdf&ref=sorena.io) - Software qualification source for MDSW decision steps, MDR/IVDR data-source boundary, and software classification handoff. - Quote: "Qualification and classification of software" - [Commission Implementing Regulation (EU) 2022/2346 on Annex XVI common specifications](https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A32022R2346&ref=sorena.io) - Binding common-specifications source for Annex XVI products without an intended medical purpose. - Quote: "common specifications" - [MDCG 2021-24 - guidance on classification of medical devices](https://health.ec.europa.eu/medical-devices-sector/new-regulations/guidance-mdcg-endorsed-documents-and-other-guidance_en/document/download/cbb19821-a517-4e13-bf87-fdc6ddd1782e_en?filename=mdcg_2021-24_en.pdf&ref=sorena.io) - Classification guidance source for escalating a positive MDR qualification conclusion into Annex VIII classification analysis. - Quote: "classification of medical devices" ## Related Topic Guides - [Custom-made medical devices under the EU MDR | EU MDR FAQ](/artifacts/eu/medical-device-regulation/faq/custom-made-devices.md): Concise EU MDR FAQ on custom-made device definition, mass-produced exclusions, Annex XIII statements, documentation, conformity assessment, PMS, vigilance, and records to retain. - [EU MDR Annex II and III Technical Documentation](/artifacts/eu/medical-device-regulation/annex-ii-and-iii-technical-documents.md): Build an MDR technical documentation index for Annex II device files and Annex III post-market surveillance evidence, including GSPR, risk, clinical, PMS, UDI, and EUDAMED records. - [EU MDR Annex VIII Classification Guide](/artifacts/eu/medical-device-regulation/annex-viii-classification.md): Classify EU MDR medical devices under Annex VIII using intended purpose, duration, invasiveness, active device and software rules, and conformity assessment impact. - [EU MDR Annex XVI products without a medical purpose](/artifacts/eu/medical-device-regulation/annex-xvi-products.md): source-linked EU MDR guide for Annex XVI products: listed product groups, common specifications, clinical evidence, notified-body route, UDI, EUDAMED, PMS, and vigilance evidence before launch. - [EU MDR Applicability Test](/artifacts/eu/medical-device-regulation/applicability-test.md): Test whether a product, accessory, software function, or Annex XVI product falls under the EU Medical Device Regulation, and record the evidence for the next classification step. - [EU MDR change assessment workflow](/artifacts/eu/medical-device-regulation/change-assessment-workflow.md): Assess EU MDR device, design, software, intended purpose, QMS, clinical, PMS, UDI, classification, and notified-body impacts before releasing a medical device change. - [EU MDR Checklist for Medical Device Compliance](/artifacts/eu/medical-device-regulation/checklist.md): Practical EU MDR checklist covering qualification, classification, conformity assessment, technical documentation, GSPR, clinical evidence, UDI, EUDAMED, PMS, vigilance, QMS, and legacy transition evidence. - [EU MDR classification workflow](/artifacts/eu/medical-device-regulation/classification-workflow.md): A concrete EU MDR classification workflow for intended purpose, device or accessory qualification, Annex VIII rule selection, Rule 11 software review, class outcome, and notified body impact. - [EU MDR Clinical Evaluation Overview](/artifacts/eu/medical-device-regulation/clinical-evaluation-overview.md): EU MDR clinical evaluation overview covering Article 61, Annex XIV, clinical data sources, equivalence, PMCF, CER evidence, notified body review, GSPR, and benefit-risk support. - [EU MDR Clinical Evaluation Report Template](/artifacts/eu/medical-device-regulation/clinical-evaluation-report-template.md): A source-linked EU MDR clinical evaluation report template covering intended purpose, GSPR linkage, clinical data appraisal, equivalence limits, PMCF, conclusions, and reviewer signoff. - [EU MDR clinical evidence guide](/artifacts/eu/medical-device-regulation/clinical-evidence.md): source-linked EU MDR guide to clinical evaluation, clinical investigations, equivalence, PMCF, GSPR support, technical documentation, and notified-body review. - [EU MDR compliance obligations](/artifacts/eu/medical-device-regulation/compliance.md): EU MDR compliance guide for device qualification, classification, conformity assessment, QMS, technical documentation, UDI, EUDAMED, PMS, vigilance, and legacy transition controls. - [EU MDR conformity route workflow](/artifacts/eu/medical-device-regulation/conformity-route-workflow.md): source-linked EU MDR workflow for classifying a device, choosing the conformity assessment route, preparing technical and QMS evidence, and reaching certificate, DoC, UDI, EUDAMED, and CE outputs. - [EU MDR deadlines and compliance calendar](/artifacts/eu/medical-device-regulation/deadlines-and-compliance-calendar.md): Grounded EU MDR calendar for application, legacy-device transition, UDI, EUDAMED, and recurring QMS, technical documentation, clinical, PMS, vigilance, certificate, and change reviews. - [EU MDR Device Classification Guide](/artifacts/eu/medical-device-regulation/device-classification-guide.md): Classify an EU MDR medical device by intended purpose, Annex VIII duration, invasiveness, active-device and software rules, then document the conformity route impact. - [EU MDR EUDAMED and UDI registration](/artifacts/eu/medical-device-regulation/eudamed-and-udi.md): source-linked MDR guide to Basic UDI-DI, UDI-DI, EUDAMED device registration, actor roles, labels, technical documentation, and UDI data governance. - [EU MDR FAQ: qualification, evidence, UDI, and transition](/artifacts/eu/medical-device-regulation/faq.md): Concise EU MDR FAQ covering device qualification, software classification, accessories, custom-made devices, clinical evidence, UDI, EUDAMED, notified bodies, significant changes, and legacy transition. - [EU MDR Legacy Device Transition](/artifacts/eu/medical-device-regulation/legacy-device-transition.md): source-linked EU MDR legacy device transition guide covering Regulation (EU) 2023/607 conditions, certificate validity, significant-change limits, surveillance, PMS, vigilance, QMS, and evidence records. - [EU MDR notified body route selection](/artifacts/eu/medical-device-regulation/notified-body-route-selection.md): Choose an EU MDR conformity assessment route by device class, Article 52 option, notified body designation scope, QMS readiness, technical documentation, clinical evidence, and certificate evidence. - [EU MDR penalties and enforcement risk](/artifacts/eu/medical-device-regulation/penalties-and-fines.md): source-linked EU MDR penalties and enforcement-risk guide covering Article 113, Member State penalty rules, market restrictions, recalls, certificate consequences, and evidence. - [EU MDR PMS and Vigilance 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 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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