---
title: "Which EUDAMED modules matter under the EU MDR?"
canonical_url: "https://www.sorena.io/artifacts/eu/medical-device-regulation/faq/eudamed-modules"
source_url: "https://www.sorena.io/artifacts/eu/medical-device-regulation/faq/eudamed-modules"
author: "Sorena AI"
description: "EU MDR FAQ mapping EUDAMED modules to actor registration, UDI/device data, certificates, clinical investigations, vigilance/PMS, market surveillance, and practical records."
published_at: "2026-05-09"
updated_at: "2026-05-09"
keywords:
  - "EU MDR EUDAMED modules"
  - "actor registration"
  - "UDI device registration"
  - "notified bodies certificates"
  - "vigilance PMS"
  - "market surveillance"
  - "EU Medical Device Regulation"
  - "EU MDR"
  - "EUDAMED Modules"
  - "EU MDR FAQ"
---
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# Which EUDAMED modules matter under the EU MDR?

EU MDR FAQ mapping EUDAMED modules to actor registration, UDI/device data, certificates, clinical investigations, vigilance/PMS, market surveillance, and practical records.

*FAQ* *EU*

## EU MDR FAQ EUDAMED Modules

EUDAMED is the MDR database for medical-device lifecycle information across economic operators, device identifiers, certificates, clinical investigations, vigilance and PMS, and market surveillance.

Use this FAQ to separate the EUDAMED module that owns each record and to avoid treating one registration entry as proof that every MDR duty is complete.

The EUDAMED modules that matter under the EU MDR are actor registration, UDI/device registration, notified bodies and certificates, clinical investigations, vigilance and post-market surveillance, and market surveillance. The practical control is to keep each submission record with the module, actor, device identifier, certificate or event, source URL, owner, and follow-up trigger it belongs to.

## Which EUDAMED modules matter under the EU MDR?

EUDAMED is not one generic evidence bucket. The Commission describes six modules: actor registration, UDI/device registration, notified bodies and certificates, clinical investigations and performance studies, vigilance and post-market surveillance, and market surveillance.

For MDR work, map the record to the module that creates or receives it. Actor registration identifies the economic operator and SRN. UDI/device registration identifies the device, Basic UDI-DI, UDI-DI, EMDN data, market status, and legacy-device links where relevant. The notified bodies and certificates module holds certificate and notified-body information. Clinical investigations, vigilance/PMS, and market surveillance each have their own electronic-system purpose under the MDR.

- Actor registration: manufacturer, authorised representative, importer, or system/procedure pack producer registration, SRN, registration request, supporting documents, and user access roles.
- UDI/device registration: Basic UDI-DI, UDI-DI, device data, EMDN code, legacy-device data where applicable, and updates to device records.
- Notified bodies and certificates: notified-body designation context, certificate information, certificate status changes, restrictions, refusals, suspensions, withdrawals, or reinstatements.
- Clinical investigations: applications, single identification numbers, substantial modifications, reports, summaries, and adverse-event reporting that the MDR routes through the clinical-investigation electronic system.
- Vigilance/PMS: serious incident reports, field safety corrective actions, field safety notices, PSURs for relevant devices, trend reports, and competent-authority coordination records.
- Market surveillance: authority inspection reports, surveillance summaries, non-compliance measures, risk evaluations, and communications between competent authorities, the Commission, and notified bodies where the MDR requires them.

Sources for this answer:

- [EUDAMED portal - European Database on Medical Devices](https://webgate.ec.europa.eu/eudamed?ref=sorena.io) - Commission EUDAMED page identifying the six EUDAMED modules and the published mandatory-use notice for the first four modules.
- [European Commission - Actor registration module](https://health.ec.europa.eu/medical-devices-eudamed/actor-registration-module_en?ref=sorena.io) - Commission module page for actor registration, Single Registration Number, actor request process, required documents, and access roles.
- [European Commission - UDI/Device registration](https://health.ec.europa.eu/medical-devices-eudamed/udidevice-registration_en?ref=sorena.io) - Commission module page for UDI/device registration, manufacturer device submissions, EMDN use, legacy-device registration, and the UDI helpdesk.
- [Regulation (EU) 2017/745 on medical devices](https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32017R0745&ref=sorena.io) - Binding MDR source for EUDAMED electronic systems covering devices, economic operators, notified bodies/certificates, clinical investigations, vigilance/PMS, and market surveillance.
- [Commission Implementing Regulation (EU) 2021/2078 on EUDAMED](https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A32021R2078&ref=sorena.io) - Implementing regulation source for EUDAMED setup, maintenance, data exchange, access, and IT security rules.

## What practical records should teams keep for EUDAMED module work?

Keep a module-level record that explains what was submitted or reviewed, why it belongs in that module, who owns the EUDAMED account action, and what must be updated when the device, certificate, incident, investigation, or authority status changes.

For actor work, retain the actor registration request, SRN, competent-authority approval trail, information-security declaration, authorised-representative mandate summary for non-EU manufacturers where applicable, and the active Local Actor Administrator coverage needed to preserve access. For UDI/device work, retain the Basic UDI-DI, UDI-DI, EMDN code, market status, certificate references where required, legacy-device link logic, version history, and update rationale.

- Link each EUDAMED record to the legal manufacturer, authorised representative, importer, or system/procedure pack producer that owns it.
- Keep UDI/device registration data aligned with the technical documentation, labels, certificates, SSCP where relevant, and change-control record.
- For certificates, keep the notified body, certificate number, certificate type, scope, status, restrictions, and any related suspension, withdrawal, reinstatement, refusal, or amendment record.
- For clinical investigations, keep the EUDAMED identifier, application dossier, substantial modifications, adverse-event reports, final report, and public summary status.
- For vigilance/PMS, keep the report type, device identifier, incident or trend facts, FSCA/FSN record, PSUR where relevant, competent-authority correspondence, and closure rationale.
- For market surveillance, keep inspection reports, non-compliance findings, measures required of economic operators, notified-body notifications, and authority communications.

Sources for this answer:

- [EUDAMED portal - European Database on Medical Devices](https://webgate.ec.europa.eu/eudamed?ref=sorena.io) - Commission EUDAMED page identifying the six EUDAMED modules and the published mandatory-use notice for the first four modules.
- [European Commission - Actor registration module](https://health.ec.europa.eu/medical-devices-eudamed/actor-registration-module_en?ref=sorena.io) - Commission module page for actor registration, Single Registration Number, actor request process, required documents, and access roles.
- [European Commission - UDI/Device registration](https://health.ec.europa.eu/medical-devices-eudamed/udidevice-registration_en?ref=sorena.io) - Commission module page for UDI/device registration, manufacturer device submissions, EMDN use, legacy-device registration, and the UDI helpdesk.
- [Regulation (EU) 2017/745 on medical devices](https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32017R0745&ref=sorena.io) - Binding MDR source for EUDAMED electronic systems covering devices, economic operators, notified bodies/certificates, clinical investigations, vigilance/PMS, and market surveillance.
- [Commission Implementing Regulation (EU) 2021/2078 on EUDAMED](https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A32021R2078&ref=sorena.io) - Implementing regulation source for EUDAMED setup, maintenance, data exchange, access, and IT security rules.

## What should not be inferred from an EUDAMED entry?

A EUDAMED entry is not the same thing as a full MDR compliance conclusion. MDR Annex VI states that presence of a device UDI-DI in the UDI database must not be assumed to mean that the device conforms with the Regulation.

Treat EUDAMED as a structured registration and reporting system. The underlying MDR evidence still sits in the QMS, technical documentation, clinical evaluation, PMS/PMCF records, vigilance files, certificate files, labels, and change-control records.

- Do not treat actor registration or an SRN as proof that device technical documentation, conformity assessment, or PMS duties are complete.
- Do not treat UDI/device registration as proof of conformity; keep the conformity evidence and device-registration record cross-referenced but separate.
- Do not mix clinical-investigation records with post-market vigilance reports unless the MDR route for the event actually requires that linkage.
- Do not cite national enforcement details, guessed module go-live dates, or future EUDAMED releases unless the source folder contains current grounded support.

Sources for this answer:

- [EUDAMED portal - European Database on Medical Devices](https://webgate.ec.europa.eu/eudamed?ref=sorena.io) - Commission EUDAMED page identifying the six EUDAMED modules and the published mandatory-use notice for the first four modules.
- [European Commission - Actor registration module](https://health.ec.europa.eu/medical-devices-eudamed/actor-registration-module_en?ref=sorena.io) - Commission module page for actor registration, Single Registration Number, actor request process, required documents, and access roles.
- [European Commission - UDI/Device registration](https://health.ec.europa.eu/medical-devices-eudamed/udidevice-registration_en?ref=sorena.io) - Commission module page for UDI/device registration, manufacturer device submissions, EMDN use, legacy-device registration, and the UDI helpdesk.
- [Regulation (EU) 2017/745 on medical devices](https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32017R0745&ref=sorena.io) - Binding MDR source for EUDAMED electronic systems covering devices, economic operators, notified bodies/certificates, clinical investigations, vigilance/PMS, and market surveillance.
- [Commission Implementing Regulation (EU) 2021/2078 on EUDAMED](https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A32021R2078&ref=sorena.io) - Implementing regulation source for EUDAMED setup, maintenance, data exchange, access, and IT security rules.

## Primary sources

- [EUDAMED portal - European Database on Medical Devices](https://webgate.ec.europa.eu/eudamed?ref=sorena.io) - Commission EUDAMED page identifying the six EUDAMED modules and the published mandatory-use notice for the first four modules.
  - Quote: "EUDAMED is composed of six modules"
- [European Commission - Actor registration module](https://health.ec.europa.eu/medical-devices-eudamed/actor-registration-module_en?ref=sorena.io) - Commission module page for actor registration, Single Registration Number, actor request process, required documents, and access roles.
  - Quote: "Actor registration is the first of the six EUDAMED modules"
- [European Commission - UDI/Device registration](https://health.ec.europa.eu/medical-devices-eudamed/udidevice-registration_en?ref=sorena.io) - Commission module page for UDI/device registration, manufacturer device submissions, EMDN use, legacy-device registration, and the UDI helpdesk.
  - Quote: "manufacturers submit in EUDAMED the UDI/Device information"
- [Regulation (EU) 2017/745 on medical devices](https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32017R0745&ref=sorena.io) - Binding MDR source for EUDAMED electronic systems covering devices, economic operators, notified bodies/certificates, clinical investigations, vigilance/PMS, and market surveillance.
  - Quote: "different electronic systems to collate and process information"
- [Commission Implementing Regulation (EU) 2021/2078 on EUDAMED](https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A32021R2078&ref=sorena.io) - Implementing regulation source for EUDAMED setup, maintenance, data exchange, access, and IT security rules.
  - Quote: "protected against threats to the availability, integrity and confidentiality"

## 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.
- [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.

*Recommended next step*

*Placement: after implementation section*

## Map EUDAMED records to the right MDR module

Use this EU MDR FAQ to separate actor, UDI/device, certificate, clinical investigation, vigilance/PMS, and market-surveillance records before building evidence workflows.

- [Open Research Copilot](/solutions/research-copilot.md): Answer EU MDR scope, timing, and interpretation questions with cited outputs.
- [Talk through implementation](/contact.md): Review your scope, evidence model, controls, and next actions.


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