---
title: "When is software regulated as SaMD under the EU MDR?"
canonical_url: "https://www.sorena.io/artifacts/eu/medical-device-regulation/faq/software-and-samd"
source_url: "https://www.sorena.io/artifacts/eu/medical-device-regulation/faq/software-and-samd"
author: "Sorena AI"
description: "Concise EU MDR FAQ on software qualification, intended medical purpose, Rule 11 classification, modules, clinical evidence, change assessment, UDI, and EUDAMED."
published_at: "2026-05-09"
updated_at: "2026-05-09"
keywords:
  - "EU MDR software"
  - "SaMD"
  - "medical device software"
  - "Rule 11"
  - "MDCG 2019-11"
  - "UDI software"
  - "EUDAMED"
  - "EU Medical Device Regulation"
  - "EU MDR"
  - "Software and SaMD"
---
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---

# When is software regulated as SaMD under the EU MDR?

Concise EU MDR FAQ on software qualification, intended medical purpose, Rule 11 classification, modules, clinical evidence, change assessment, UDI, and EUDAMED.

*FAQ* *EU MDR*

## When is software regulated as SaMD under the EU MDR?

Software is regulated under the MDR when the manufacturer gives it an intended medical purpose, or when it drives, influences, or forms part of a medical device in the regulatory process.

Use this FAQ to separate non-medical software from medical device software, apply Rule 11 where relevant, and keep software evidence aligned with technical documentation, clinical evaluation, UDI, EUDAMED, and change control.

Under the EU MDR, software is not regulated as SaMD just because it is used in healthcare. The key question is the manufacturer's intended purpose: software with its own medical purpose can be medical device software, while simple storage, archiving, communication, simple search, invoicing, staff planning, or lifestyle/wellbeing functions do not qualify on that basis alone.

## When does software qualify as medical device software?

Start with the intended purpose stated in labels, instructions for use, promotional material, sales statements, and the clinical evaluation. MDR Article 2 includes software in the medical-device definition when it is intended for medical purposes such as diagnosis, prevention, monitoring, prediction, prognosis, treatment, or alleviation of disease, or diagnosis, monitoring, treatment, alleviation, or compensation for injury or disability.

MDCG 2019-11 turns that into a practical software test. Software may qualify where it processes, analyses, creates, or modifies medical information for the benefit of individual patients and for a medical intended purpose. Software that only stores, archives, communicates, performs simple search, or performs lossless compression is not medical device software on that function alone.

Software that drives or influences a hardware medical device is still covered in the device's regulatory process as a part, component, or accessory, even if it does not create medical information on its own.

- Record the intended medical purpose, patient population, user group, input data, output data, and claim text before assigning the MDR class.
- Separate independent medical device software from software embedded in, connected to, or controlling a hardware device.
- Do not qualify an entire platform automatically; identify the modules that have a medical purpose and the boundaries and interfaces with non-medical modules.

Sources for this answer:

- [Regulation (EU) 2017/745 on medical devices](https://eur-lex.europa.eu/eli/reg/2017/745/oj?ref=sorena.io) - Binding MDR source for the medical-device definition, intended purpose, software as an active device, technical documentation, clinical evaluation, and UDI obligations.
- [MDCG 2019-11 - 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 for medical device software qualification, non-qualifying software functions, software driving or influencing hardware devices, Rule 11, modules, and software change considerations.

## How does Rule 11 classify MDR software?

After qualification, classify the software from its intended purpose and Annex VIII rules. For independent medical device software, MDCG 2019-11 points to Rule 11 for software that provides information used for diagnosis or therapeutic decisions, or software intended to monitor physiological processes.

Rule 11 generally classifies software used for diagnostic or therapeutic decisions as class IIa, unless the decision impact may cause death or irreversible deterioration, which moves it to class III, or serious deterioration or surgical intervention, which moves it to class IIb. Software intended to monitor physiological processes is class IIa, except vital-parameter monitoring where variations could create immediate patient danger, which is class IIb. Other software is class I.

If software drives or influences a device, Annex VIII implementing rules matter too: software can fall in the same class as the device, independent software is classified in its own right, and the strictest applicable rule controls where multiple rules apply.

- Keep a Rule 11 memo covering diagnosis or therapy decision impact, monitoring purpose, vital-parameter risk, and any hardware-device rule that also applies.
- Map each medical module separately when the product combines administrative, display, communication, decision-support, monitoring, or control functions.
- Tie the class outcome to the conformity assessment route, notified-body involvement, technical documentation index, and release approval.

Sources for this answer:

- [Regulation (EU) 2017/745 on medical devices](https://eur-lex.europa.eu/eli/reg/2017/745/oj?ref=sorena.io) - Binding MDR source for Annex VIII classification rules and implementing rules for software and active devices.
- [MDCG 2019-11 - 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 explaining Rule 11, software driving or influencing devices, module boundaries, and examples of software classification under the MDR.

## What evidence should software teams keep?

Keep a qualification and classification file that a reviewer can follow without product-history context. It should show the intended purpose, claims, users, patient population, input data, output data, medical action, module boundaries, Rule 11 analysis, applicable Annex VIII rules, and final class.

For MDR software, technical documentation should connect the software description to risk management, verification and validation, cybersecurity and usability evidence where relevant, clinical evaluation, PMS or PMCF planning, labels, IFU, UDI identifiers, and EUDAMED device-registration data where the software is placed on the market as a device.

Clinical evaluation is not optional for software with medical claims. MDR Annex XIV requires a clinical evaluation plan and report, with clinical data relevant to the device and intended purpose, gaps in clinical evidence, favourable and unfavourable data, and PMCF where needed to update the evaluation after market release.

- Use the same intended purpose across claims, IFU, clinical evaluation, technical documentation, classification memo, certificate scope, UDI records, and EUDAMED submissions.
- For software commercially available on its own and constituting a device in itself, assign UDI at the software system level and display software identification in the UDI-PI where applicable.
- Assess software changes before release: new or changed algorithms, architecture, operating-system dependencies, user interfaces, interoperability channels, medical features, or closed-loop behavior can change qualification, classification, safety, performance, or registration data.

Sources for this answer:

- [Regulation (EU) 2017/745 on medical devices](https://eur-lex.europa.eu/eli/reg/2017/745/oj?ref=sorena.io) - Binding MDR source for technical documentation, clinical evaluation, PMCF, UDI, and conformity assessment records.
- [MDCG 2020-3 Rev.1 - significant changes under MDR Article 120](https://health.ec.europa.eu/medical-devices-sector/new-regulations/guidance-mdcg-endorsed-documents-and-other-guidance_en/document/download/800e8e87-d4eb-4cc5-b5ad-07a9146d7c90%5Fen?filename=mdcg%5F2020-3%5Fen%5F1.pdf&ref=sorena.io) - MDCG source for software-change examples, including bug fixes, cybersecurity updates, operating-system changes, architecture changes, algorithm changes, UI changes, new medical features, and interoperability changes.
- [European Commission - UDI/Device registration](https://health.ec.europa.eu/medical-devices-eudamed/udidevice-registration_en?ref=sorena.io) - Commission source for UDI/device registration and manufacturer submission of UDI/device information in EUDAMED.
- [EUDAMED portal](https://webgate.ec.europa.eu/eudamed?ref=sorena.io) - Commission portal source for EUDAMED purpose and module structure, including actor registration, UDI/devices, notified bodies and certificates, clinical investigations, vigilance/PMS, and market surveillance.

## Primary sources

- [Regulation (EU) 2017/745 on medical devices](https://eur-lex.europa.eu/eli/reg/2017/745/oj?ref=sorena.io) - Binding MDR source for medical-device definition, intended purpose, software as an active device, Annex VIII classification, technical documentation, clinical evaluation, UDI, and conformity assessment.
  - Quote: "software shall also be deemed to be an active device"
- [MDCG 2019-11 - 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 medical device software qualification, Rule 11 classification, software that drives or influences hardware devices, modules, and software change considerations.
  - Quote: "Software must have a medical purpose on its own"
- [MDCG 2020-3 Rev.1 - significant changes under MDR Article 120](https://health.ec.europa.eu/medical-devices-sector/new-regulations/guidance-mdcg-endorsed-documents-and-other-guidance_en/document/download/800e8e87-d4eb-4cc5-b5ad-07a9146d7c90%5Fen?filename=mdcg%5F2020-3%5Fen%5F1.pdf&ref=sorena.io) - MDCG guidance source for software-change significance examples and change-control reassessment triggers.
  - Quote: "new medical feature or functionality"
- [European Commission - UDI/Device registration](https://health.ec.europa.eu/medical-devices-eudamed/udidevice-registration_en?ref=sorena.io) - Commission source for UDI/device registration and EUDAMED device-information submission context.
  - Quote: "manufacturers submit in EUDAMED the UDI/Device information"
- [EUDAMED portal](https://webgate.ec.europa.eu/eudamed?ref=sorena.io) - Commission portal source for EUDAMED purpose and six-module structure.
  - Quote: "EUDAMED is composed of six modules"

## 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 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.
- [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.

*Recommended next step*

*Placement: after evidence section*

## Review MDR software qualification and Rule 11 evidence

Check whether your software has an MDR medical purpose, which modules are regulated, which Rule 11 class applies, and whether technical documentation, clinical evaluation, UDI, EUDAMED, and change records stay aligned.

- [Open Research Copilot](/solutions/research-copilot.md): Check MDR software qualification, classification, and source-linked evidence.
- [Talk through implementation](/contact.md): Review software scope, module boundaries, Rule 11 class, and technical-file evidence.


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