--- title: "Applicability Test" canonical_url: "https://www.sorena.io/artifacts/eu/medical-device-regulation/applicability-test" source_url: "https://www.sorena.io/artifacts/eu/medical-device-regulation/applicability-test" author: "Sorena AI" description: "A step-by-step MDR applicability test for Regulation (EU) 2017/745: confirm intended purpose, device definition and exclusions." published_at: "2026-02-22" updated_at: "2026-02-22" keywords: - "EU MDR applicability test" - "MDR scope test" - "Regulation (EU) 2017/745 in scope" - "is it a medical device" - "MDR device definition" - "MDR intended purpose" - "Annex XVI products common specifications" - "software as a medical device MDR" - "MDR Rule 11 software classification" - "economic operator role MDR manufacturer importer distributor authorised representative" - "MDR conformity assessment route" - "CE marking medical devices" - "EU MDR" - "Regulation (EU) 2017/745" - "Applicability Test" - "Scope" - "Classification" - "EUDAMED" --- **[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) --- # Applicability Test A step-by-step MDR applicability test for Regulation (EU) 2017/745: confirm intended purpose, device definition and exclusions. *Applicability* *EU* ## EU Medical Device Regulation (MDR) Applicability Test Decide scope, role, and the next compliance workstream - with defensible reasoning. Output: a scope memo + classification hypothesis + conformity route shortlist + evidence plan (technical file, clinical evaluation, PMS, UDI/EUDAMED). Most MDR failures start with a weak scope decision: unclear intended purpose, confusing wellness vs medical claims, or missing the difference between medical device software and software that only supports an administrative process. This page gives you a practical, reviewable decision sequence you can run per product family and keep as a living scope memo in your technical documentation. ## Before you start: capture the minimum facts (so your scope decision survives review) A defensible MDR applicability decision depends on stable product facts. If you can't answer these, pause and collect the data before you contact a notified body or draft a clinical evaluation. Output: a one-page scope memo per product family (not per SKU). - Intended purpose and claims: what you say the product does (label, IFU, marketing, UI, sales collateral). - User + use environment: patient vs professional, clinical setting vs home, intended population and contraindications. - Mode of action: physical, mechanical, thermal, electromagnetic, software logic, decision support, monitoring/measurement. - What the product is: hardware, software (standalone or embedded), accessory, system/procedure pack, kit, combination product. - Supply chain reality: who places on the market under their name/trademark; who imports/distributes; who changes/relables. ## Step 1 - Does the intended purpose fit the MDR medical device definition? MDR scope hinges on intended purpose: prevention, diagnosis, monitoring, prediction/prognosis, treatment or alleviation of disease/injury/disability; investigation/replacement/modification of anatomy or a physiological process/state; or control/support of conception. Control: your scope memo should quote your intended purpose statement verbatim and map each claim to a clinical benefit and a risk control. - If you rely on wellness positioning, check every claim, UI string, and output label for diagnosis/monitoring language. - If the product influences clinical decisions (including algorithmic recommendations), define the decision context and harm scenario. - If you are an accessory, your intended purpose must support a medical device, and you still have MDR obligations. ## Step 2 - Borderline and exclusion checks (don't assume you're in scope) Borderline classification is common for apps, wearable platforms, laboratory workflow tools, and products with mixed consumer/clinical claims. Treat borderline analysis as a required artifact, not a debate. Control: include an exclusions checked subsection with 1-2 sentence rationales, and keep it updated when claims change. - Software: differentiate medical device software from software that only stores/transmits data without medical purpose. - Combination/dual-use: if you claim both consumer and medical use, MDR obligations follow the medical intended purpose. - Accessories and systems: check whether you're composing a system/procedure pack or integrating third-party devices. ## Step 3 - Annex XVI check: products without an intended medical purpose can still be in scope The MDR also covers certain product groups without an intended medical purpose (Annex XVI) when common specifications apply. This is where many consumer products get surprised by MDR-like duties. Control: if you match Annex XVI, record which group you match and which common specifications you will use. - If you sell cosmetic-style products in an Annex XVI group, plan risk management and (where required) clinical evaluation for safety. - Use the implementing regulation on common specifications to drive evidence expectations and labeling language. - Treat Annex XVI like MDR obligations with a different purpose statement and build the same operational capability. ## Step 4 - Identify your role (manufacturer vs importer vs distributor vs authorised representative) MDR obligations depend heavily on your role. Many teams discover too late that relabeling, translation, repackaging, or software updates can shift responsibilities. Control: include an economic operator map in your scope memo (legal entity, responsibilities, and handoffs). - Manufacturer obligations are the broadest: QMS, technical documentation, clinical evaluation, PMS, vigilance, UDI/EUDAMED. - Importers and distributors have specific verification duties (e.g., CE marking, DoC availability, storage/transport conditions). - Authorised representatives carry defined obligations; align contracts and change-control with your QMS. ## Step 5 - Classification hypothesis (Annex VIII): this drives cost, timelines, and notified body involvement Once you believe you are in scope, create a classification hypothesis and test it. Classification drives the conformity assessment route and evidence depth. Control: write a classification memo that cites the rules you used and the device characteristics that trigger them. - For software, pay special attention to MDR Rule 11 and MDCG guidance on qualification/classification of software. - For invasiveness and duration of contact, map device characteristics clearly and consistently across labeling, IFU, and clinical evaluation. - If your classification drives notified body involvement, plan lead times and application readiness early. ## Step 6 - Decide the next path: conformity assessment + evidence chain Applicability is not the end - it determines the workstream. Your next steps should be a route decision (Annex IX/X/XI), a technical file index (Annex II/III), and an evidence plan (clinical evaluation + PMS). Control: keep the route decision and evidence plan as living documents; update them when design, claims, or intended purpose changes. - Start with the MDR checklist and turn it into owners, evidence, and acceptance criteria. - Build technical documentation structure early; it reduces rework and speeds notified body interactions. - Operationalise PMS/vigilance and UDI/EUDAMED as product operations, not as paperwork at the end *Recommended next step* *Placement: after the applicability result* ## Turn EU Medical Device Regulation (MDR) Applicability Test into an operational assessment Assessment Autopilot can take EU Medical Device Regulation (MDR) Applicability Test from deciding whether these obligations apply in practice to a reusable workflow inside Sorena. Teams working on EU Medical Device Regulation (MDR) can keep owners, evidence, and next steps aligned without copying this guide into separate documents. - [Open Assessment Autopilot for EU Medical Device Regulation (MDR) Applicability Test](/solutions/assessment.md): Start from EU Medical Device Regulation (MDR) Applicability Test and turn the guidance into owned tasks, evidence requests, and review checkpoints. - [Talk through EU Medical Device Regulation (MDR)](/contact.md): Review your current process, evidence gaps, and next steps for EU Medical Device Regulation (MDR) Applicability Test. ## Primary sources - [Regulation (EU) 2017/745 - Medical Device Regulation (MDR) (EUR-Lex)](https://eur-lex.europa.eu/eli/reg/2017/745/oj?ref=sorena.io) - Primary legal text for scope/definitions, economic operators, classification framework, conformity assessment, technical documentation, clinical evaluation, PMS/vigilance, UDI and EUDAMED. - [Commission Implementing Regulation (EU) 2022/2346 - Common specifications for Annex XVI products (EUR-Lex)](https://eur-lex.europa.eu/eli/reg_impl/2022/2346/oj?ref=sorena.io) - Common specifications for product groups without an intended medical purpose listed in MDR Annex XVI. - [MDCG 2019-11 rev.1 - Qualification and classification of software (MDR/IVDR) (European Commission)](https://health.ec.europa.eu/document/download/b45335c5-1679-4c71-a91c-fc7a4d37f12b%5Fen?filename=mdcg%5F2019%5F11%5Fen.pdf&ref=sorena.io) - High-signal guidance for deciding whether software is a medical device and for applying classification rules (including Rule 11 patterns and examples). - [MDCG 2021-24 - Guidance on classification of medical devices (European Commission)](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%5Fen?filename=mdcg%5F2021-24%5Fen.pdf&ref=sorena.io) - Practical guidance and examples for applying MDR Annex VIII classification rules. - [Blue Guide 2022 - Commission Notice 2022/C 247/01 (EUR-Lex)](https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A52022XC0628%2804%29&ref=sorena.io) - Guidance on intended purpose, placing/making available on the market, multi-legislation products, and compliance concepts. ## Related Topic Guides - [CER Template | EU Medical Device Regulation (MDR) 2017/745 | Clinical Evaluation Report Structure (Annex XIV)](/artifacts/eu/medical-device-regulation/clinical-evaluation-report-template.md): A practical Clinical Evaluation Report (CER) template for MDR (Regulation (EU) 2017/745): a copy-ready CER structure aligned to Annex XIV. - [Clinical Evaluation Overview | EU Medical Device Regulation (MDR) 2017/745 | CER, Clinical Evidence Strategy, PMCF](/artifacts/eu/medical-device-regulation/clinical-evaluation-overview.md): A practical MDR clinical evaluation overview: how to define clinical claims and intended purpose, plan the clinical evaluation (CEP). - [Compliance Checklist | EU Medical Device Regulation (MDR) 2017/745 | Technical Documentation, Clinical Evaluation, PMS, UDI/EUDAMED](/artifacts/eu/medical-device-regulation/checklist.md): An MDR compliance checklist you can run per device family: scope + role, classification and conformity assessment route, QMS controls (incl. - [Compliance Guide | EU Medical Device Regulation (MDR) 2017/745 | QMS, Technical Documentation, Clinical Evaluation, PMS, UDI/EUDAMED](/artifacts/eu/medical-device-regulation/compliance.md): A practical EU MDR compliance guide for Regulation (EU) 2017/745: how to build an MDR operating model from scope and classification to conformity assessment. - [Deadlines and Compliance Calendar | EU Medical Device Regulation (MDR) 2017/745 | Transition, Legacy Devices, EUDAMED](/artifacts/eu/medical-device-regulation/deadlines-and-compliance-calendar.md): A practical MDR deadlines and compliance calendar: MDR application timing, Regulation (EU) 2023/607 transition conditions. - [Device Classification Guide | EU Medical Device Regulation (MDR) 2017/745 | Annex VIII + Software Rule 11](/artifacts/eu/medical-device-regulation/device-classification-guide.md): A practical MDR device classification guide for Annex VIII: how to write a classification memo, apply implementing rules, decide invasiveness and duration. - [FAQ | EU Medical Device Regulation (MDR) 2017/745 | Scope, Classification, Technical File, Clinical Evaluation, UDI/EUDAMED](/artifacts/eu/medical-device-regulation/faq.md): High-signal EU MDR FAQ: Is my product a medical device? Is my software in scope? What is Rule 11? Do I need a notified body? What goes in the technical file. - [MDR vs IVDR | EU Medical Device Regulation (MDR) 2017/745 vs IVDR 2017/746 | Classification, Evidence, UDI/EUDAMED](/artifacts/eu/medical-device-regulation/mdr-vs-ivdr.md): A practical MDR vs IVDR comparison for mixed device portfolios: scope differences (medical devices vs in vitro diagnostics), classification approaches. - [Penalties and Fines | EU Medical Device Regulation (MDR) 2017/745 | Enforcement Risk + How to Reduce Exposure](/artifacts/eu/medical-device-regulation/penalties-and-fines.md): A practical MDR enforcement guide: how penalties work under EU MDR (sanctions set by Member States), common enforcement triggers (misleading claims. - [PMS and Vigilance | EU Medical Device Regulation (MDR) 2017/745 | PMS Plan, PSUR, Serious Incidents, FSCA](/artifacts/eu/medical-device-regulation/post-market-surveillance-and-vigilance.md): A practical MDR PMS and vigilance guide: build the Annex III PMS system, decide when PSUR or PMS report applies, meet serious-incident timelines of 15 days. - [PMS Plan Template | EU Medical Device Regulation (MDR) 2017/745 | Annex III-Aligned Outline + Metrics](/artifacts/eu/medical-device-regulation/post-market-surveillance-plan-template.md): A practical MDR Post-Market Surveillance (PMS) plan template aligned to MDR Annex III: copy-ready sections for device scope, data sources. - [QMS and Technical File | EU Medical Device Regulation (MDR) 2017/745 | Annex II/III Technical Documentation + QMS Controls](/artifacts/eu/medical-device-regulation/qms-and-technical-file.md): A practical MDR QMS and technical-file guide: Article 10 and 15 governance, Annex II and III file structure, GSPR traceability. - [Requirements | EU Medical Device Regulation (MDR) 2017/745 | Core Obligations + Evidence Outputs](/artifacts/eu/medical-device-regulation/requirements.md): A grounded MDR requirements guide for Regulation (EU) 2017/745: scope and role mapping, Annex VIII classification, Article 10 and 15 governance. - [Transition Timelines | EU Medical Device Regulation (MDR) 2017/745 | Legacy Devices, 2023/607 Extension, Significant Changes](/artifacts/eu/medical-device-regulation/transition-timelines.md): A practical MDR transition and legacy-device timeline guide: how Article 120 works after Regulation (EU) 2023/607, which conditions must stay true. - [UDI and EUDAMED | EU Medical Device Regulation (MDR) 2017/745 | UDI-DI/PI, Basic UDI-DI, Actor Registration, Device Registration](/artifacts/eu/medical-device-regulation/udi-and-eudamed.md): A practical MDR UDI and EUDAMED guide: Basic UDI-DI, UDI-DI, UDI-PI, actor registration and SRN, Article 29 device registration. --- [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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