{"head":{"title":"EU MDR Software Classifier (Rule 11) | OceanLab","description":"Answer a few questions to see whether your software may be a medical device under the EU MDR and its likely Rule 11 class: I, IIa, IIb or III.","canonical":"https://oceanlab.in/tools/mdr-software-classifier"},"tool":{"slug":"mdr-software-classifier","path":"/tools/mdr-software-classifier","name":"MDR software classifier","h1":"EU MDR software classifier","lede":"Check whether your software may be a medical device in the EU and which class Rule 11 would likely give it.","category":"compliance","categoryTitle":"Compliance checklists","method":["First, Article 2(1) of Regulation (EU) 2017/745: software is a medical device only if the manufacturer intends it for a medical purpose, such as diagnosis, monitoring or treatment of disease.","Then Annex VIII, Rule 11, quoted in full on the page: decision support is class IIa, IIb for serious harm or surgery, III for death or irreversible harm. Monitoring is IIa, or IIb for vital parameters with immediate danger. All other software is class I.","When both decision support and monitoring apply, the stricter class wins. Other Annex VIII rules can also apply and are not checked here.","MDCG 2019-11 rev.1 (June 2025) is the Commission-endorsed guidance with worked examples. Read it before relying on a result."],"sources":[{"label":"Regulation (EU) 2017/745 (MDR), Official Journal text","url":"http://data.europa.eu/eli/reg/2017/745/oj","checkedAt":"2026-10-25"},{"label":"MDCG 2019-11 rev.1: qualification and classification of software (June 2025)","url":"https://health.ec.europa.eu/medical-devices-sector/new-regulations/guidance-mdcg-endorsed-documents-and-other-guidance_en","checkedAt":"2026-10-25"}],"faq":[{"question":"Is a wellness app a medical device?","answer":"Not if it has no medical purpose under Article 2(1). The intended purpose in your labelling, store listing and marketing decides it, so check what you claim."},{"question":"Why is most decision-support software class IIa or higher?","answer":"Rule 11 starts any software that informs diagnosis or therapy decisions at class IIa, and raises it with the harm a wrong decision could cause."},{"question":"What about in vitro diagnostic software?","answer":"Software for in vitro diagnostic purposes falls under Regulation (EU) 2017/746 (IVDR). MDCG 2019-11 covers both regulations."},{"question":"Is this legal advice?","answer":"No. It is a first-pass check to plan engineering and regulatory work. Your regulatory lead or notified body decides."}],"notice":{"title":"Guidance, not legal advice.","text":"This is a first-pass classification; your regulatory lead or notified body decides."},"updatedAt":"2026-10-25"},"related":[{"href":"/tools/eu-ai-act-risk-checker","label":"EU AI Act risk checker","detail":"Answer a few questions about your AI system to see its likely risk tier, what you would have to do, and from when."},{"href":"/tools/telehealth-app-cost","label":"Telehealth app cost","detail":"Pick the telehealth features and platforms and get a cost and timeline range, with what each feature adds."},{"href":"/tools/hipaa-risk-assessment","label":"HIPAA risk assessment","detail":"Work through a HIPAA security risk analysis in 17 steps, from scoping ePHI to the fix plan, and export your progress."}],"studies":[{"meta":{"slug":"leitstern","industry":"telehealth","projectType":"AI symptom checker","country":"at","tags":["healthcare","ai","enterprise"],"compliances":["EU MDR (class IIa)","ISO 13485","ISO 14971","IEC 62304","IEC 62366-1","EU AI Act","GDPR","Austrian DSG","WCAG 2.1 AA"],"cover":{"src":"/case-studies/leitstern/01-home.png","width":1440,"height":1000}},"text":{"en":{"title":"Leitstern - AI Symptom Checker with a Clinical Governance Console","description":"Designed and built the clinical governance console for a CE-marked symptom checker that tells people in Austria how urgently to seek care: releases of clinical content, red-flag rules and locked models approved by e-signature against a passing regression run, real-world under-triage tracked from follow-ups, and vigilance deadlines kept in view.","category":"Telehealth / AI Symptom Checker","client":"Donauhain Health"}}},{"meta":{"slug":"lichtung","industry":"mental","projectType":"AI journaling app","country":"de","tags":["healthcare","ai"],"compliances":["DiGA (DVG and DiGAV)","EU MDR","BSI TR-03161","GDPR","BDSG","EU AI Act","HWG"],"cover":{"src":"/case-studies/lichtung/01-home.png","width":1440,"height":1000}},"text":{"en":{"title":"Lichtung - Prescribable AI Journaling App with a Clinical Safety Console","description":"Designed and built a clickable clinical console for a prescribable CBT journaling app on the German DiGA pathway: clinical review of every patient-facing text, an AI release register with safety gates and sign-offs, and a crisis detection log that staff review without ever reading a journal entry.","category":"Mental Health & Wellness / AI Journaling","client":"Auenwald Health GmbH"}}},{"meta":{"slug":"luwte","industry":"mental","projectType":"Meditation & sleep app","country":"nl","tags":["healthcare","saas"],"compliances":["EU MDR (wellness positioning)","GDPR","UAVG","Telecommunicatiewet (ePrivacy)","Unfair Commercial Practices Directive","Consumer Rights Directive","ACM dark-pattern guidance","Digital Markets Act","European Accessibility Act","WCAG 2.1 AA"],"cover":{"src":"/case-studies/luwte/01-home.png","width":1440,"height":1000}},"text":{"en":{"title":"Luwte - Meditation and Sleep App with a Content Studio and Ethical Growth Guardrails","description":"Designed and built a clickable content studio console for a Dutch meditation and sleep subscription in four languages: a pipeline that takes every session from brief to release, mastering checks against the house loudness standard, a rights register that warns before licences run out, and growth experiments that cannot start without an ethics review.","category":"Mental Health & Wellness / Meditation & Sleep","client":"Zeegras Wellness B.V."}}},{"meta":{"slug":"atalaya","industry":"clinics","projectType":"Radiology workflow","country":"es","tags":["healthcare","ai","enterprise"],"compliances":["GDPR","LOPDGDD","Ley 41/2002","Directive 2013/59/Euratom","RD 601/2019","ENS (RD 311/2022)","EU MDR 2017/745","EU AI Act","HL7 v2 and FHIR","DICOM and IHE"],"cover":{"src":"/case-studies/atalaya/01-home.png","width":1440,"height":1000}},"text":{"en":{"title":"Atalaya - Radiology Information System from Order to Signed Report","description":"Designed and built a clickable radiology information system for a private imaging group with nine centres in Andalucía, Madrid and Cataluña: radiologists protocol orders against safety rules, read from one worklist ranked by urgency and time to SLA, sign structured reports behind a pre-sign checklist, and prove every critical finding reached a clinician.","category":"Healthcare / Radiology Workflow","client":"Albariza Diagnóstico por Imagen"}}}],"more":[{"href":"/case-studies/industry/telehealth","label":"Telehealth & patient apps case studies","detail":"Every OceanLab product build in Telehealth & patient apps."},{"href":"/case-studies/industry/mental","label":"Mental health & wellness case studies","detail":"Every OceanLab product build in Mental health & wellness."},{"href":"/case-studies/industry/clinics","label":"Hospitals & clinics case studies","detail":"Every OceanLab product build in Hospitals & clinics."},{"href":"/case-studies","label":"All case studies","detail":"Every OceanLab product build."},{"href":"/ai-automation","label":"AI automation","detail":"AI built into real business workflows, with people in charge."}],"today":"2026-10-25"}