---
title: "EU MDR EUDAMED and UDI registration"
canonical_url: "https://www.sorena.io/artifacts/eu/medical-device-regulation/eudamed-and-udi"
source_url: "https://www.sorena.io/artifacts/eu/medical-device-regulation/eudamed-and-udi"
author: "Sorena AI"
description: "source-linked MDR guide to Basic UDI-DI, UDI-DI, EUDAMED device registration, actor roles, labels, technical documentation, and UDI data governance."
published_at: "2026-05-09"
updated_at: "2026-05-09"
keywords:
  - "EU MDR EUDAMED"
  - "MDR UDI"
  - "Basic UDI-DI"
  - "UDI-DI"
  - "EUDAMED device registration"
  - "medical device data governance"
  - "EU Medical Device Regulation"
  - "EU MDR"
  - "Regulation (EU) 2017/745"
  - "EUDAMED"
---
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---

# EU MDR EUDAMED and UDI registration

source-linked MDR guide to Basic UDI-DI, UDI-DI, EUDAMED device registration, actor roles, labels, technical documentation, and UDI data governance.

*Artifact Guide* *EU*

## EU MDR EUDAMED and UDI

Under the EU MDR, manufacturers use UDI assignments, device registration, technical documentation, and EUDAMED records to identify and trace devices placed on the EU market.

Use this page to align Basic UDI-DI, UDI-DI, EUDAMED actor records, label data, importer checks, and QMS controls without inventing unsupported deadlines or loose compliance labels.

EUDAMED and UDI work under the MDR is a data-control exercise: identify the legal actor, assign and govern the Basic UDI-DI and UDI-DI, register device data in the right EUDAMED module, keep label and technical-file references consistent, and preserve evidence for authority, notified-body, importer, vigilance, and post-market use.

## What EUDAMED and UDI cover under the MDR

EUDAMED is the MDR database architecture for actor registration, UDI and device registration, notified bodies and certificates, clinical investigations, vigilance and post-market surveillance, and market surveillance. For this artifact, the working scope is the actor and UDI/device-registration data that identifies a device, the responsible economic operators, and the records that later connect to certificates, vigilance, PMS, and public transparency.

The Commission UDI/device-registration page states that the MDR introduced a UDI-based identification system for traceability and that manufacturers must submit UDI/device information in EUDAMED for devices they place on the EU market. It also identifies the UDI/Devices module as mandatory to use from 28 May 2026, after the functionality notice and transition period described in the EUDAMED materials.

- Treat EUDAMED as the shared registration system, not as a substitute for the manufacturer's QMS, technical documentation, label-control, or release approval records.
- Track actor registration separately from device registration: manufacturers, authorised representatives, importers, and system or procedure pack producers can have role-specific EUDAMED registrations and SRNs.
- Use EUDAMED module status only where grounded in current Commission material; do not add local penalty rules, speculative module dates, or national validation timelines.

Sources for this answer:

- [EUDAMED portal](https://webgate.ec.europa.eu/eudamed?ref=sorena.io) - Commission portal source for EUDAMED purpose, six-module structure, EU Login access, Local Actor Administrator warning, and first-four-module mandatory-use statement.
- [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, manufacturer submission of UDI/device information, EMDN use, voluntary entry since October 2021, and UDI/Devices module mandatory use from 28 May 2026.
- [Commission Implementing Regulation (EU) 2021/2078 on EUDAMED](https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A32021R2078&ref=sorena.io) - Binding implementing regulation for EUDAMED access, restricted website registration, EMDN use, support, data processing, malfunction handling, testing, and IT security rules.

## UDI-DI, Basic UDI-DI, and device-registration links

Separate the identifiers before assigning owners. The Basic UDI-DI groups devices with the same intended purpose, risk class, and essential design and manufacturing characteristics, and it appears in MDR evidence such as the declaration of conformity, technical documentation, certificates, SSCP and PSUR where applicable. The UDI-DI identifies the specific device model or package configuration for EUDAMED registration and traceability.

A new UDI-DI is needed when a change could cause device misidentification or ambiguity in traceability. MDCG 2022-7 lists examples including changes to name or trade name, device version or model, single-use labelling, sterile packaging, need for sterilisation before use, and package quantity. That makes UDI change control a release-gate question, not a post-launch database cleanup.

- Create or confirm the Basic UDI-DI before certificates, declarations, technical documentation references, SSCP, PSUR, and EUDAMED device records depend on it.
- Control UDI-DI changes through labelled attributes, packaging configuration, sterile state, model/version, and device-quantity change review.
- Record the issuing entity rules used, the exact device configuration, the EMDN code, and the EUDAMED submission status for each marketed device record.

Sources for this answer:

- [Regulation (EU) 2017/745 on medical devices](https://eur-lex.europa.eu/eli/reg/2017/745/2023-03-20?ref=sorena.io) - MDR source for manufacturer UDI and registration obligations, importer verification duties, Article 29 device registration, Article 31 actor registration, and Annex II technical documentation context.
- [MDCG 2022-7 - UDI system Q&A](https://health.ec.europa.eu/system/files/2022-05/mdcg_2022-7_en.pdf?ref=sorena.io) - MDCG Q&A source for UDI-DI change triggers, Basic UDI-DI use, UDI labelling, systems and procedure packs, configurable devices, and UDI/EUDAMED questions.
- [European Commission - UDI/Device registration](https://health.ec.europa.eu/medical-devices-eudamed/udidevice-registration_en?ref=sorena.io) - Commission source for the Basic UDI-DI and UDI-DI concept, UDI/device datasets, EMDN, legacy-device registration, and EUDAMED device-registration documentation.

## Manufacturer, importer, and actor-record responsibilities

The manufacturer owns the MDR UDI and registration baseline: Article 10 requires manufacturers to comply with UDI obligations and device-registration obligations, and the QMS must verify UDI assignments and keep information submitted for device registration consistent and valid. For non-EU manufacturers, the authorised representative and competent-authority validation path affect actor registration; for importers, the MDR requires checks that the manufacturer has assigned a UDI where applicable and that the device is registered in the electronic system.

Actor data is not just an admin form. The actor module Q&A states that manufacturer names used in actor registration must match the name on the device label and official documents such as certificates and technical documentation. It also explains that an economic operator with multiple roles needs separate registration requests and receives a specific SRN for each actor role.

- Maintain one actor master record per legal entity and role, with label name, registered address, authorised representative link where relevant, PRRC information where required, and SRN status.
- Require importer onboarding checks to verify UDI assignment, device registration, manufacturer and authorised-representative details, and any role-specific EUDAMED linkage.
- Keep at least two active Local Actor Administrators for EUDAMED access governance, because the portal warns that a single LAA loss can remove actor access.

Sources for this answer:

- [Regulation (EU) 2017/745 on medical devices](https://eur-lex.europa.eu/eli/reg/2017/745/2023-03-20?ref=sorena.io) - MDR source for manufacturer Article 10 UDI/QMS obligations and importer Article 13 verification of UDI assignment and device registration.
- [EUDAMED actor module Q&A](https://health.ec.europa.eu/medical-devices-sector/new-regulations/guidance-mdcg-endorsed-documents-and-other-guidance_en/document/download/8e9adf30-71b5-4faf-a8fb-b35ce4804440%5Fen?filename=md%5Fmdcg%5F2021-13%5Fq-a-actor%5Fregistr%5Feudamed%5Fen.pdf&ref=sorena.io) - Commission Q&A source for actor-registration validation, role-specific SRNs, manufacturer-name matching, importer-manufacturer linking, distributor non-registration, and custom-made-device actor-registration limits.
- [EUDAMED portal](https://webgate.ec.europa.eu/eudamed?ref=sorena.io) - Commission portal source for EU Login access and the warning to maintain at least two active Local Actor Administrators for an actor.

## Labels, technical documentation, and QMS data governance

UDI governance should be embedded in design control, label approval, packaging control, declaration and certificate preparation, technical documentation maintenance, and post-market workflows. MDCG 2021-19 links UDI integration to the QMS and states that the UDI and Basic UDI-DI should be referenced across the technical file, declaration, reports, certificates, SSCP and PSUR where applicable.

The practical control is a cross-reference table, not a memo. For each device and packaging level, keep the Basic UDI-DI, UDI-DI, UDI-PI logic, issuing entity, EMDN code, risk class, intended purpose, label artwork reference, IFU reference, technical-file section, EUDAMED record state, release owner, and change trigger. Reconcile the table before label release, certificate updates, importer onboarding, vigilance submissions, and market withdrawals or recalls.

- Before release, compare label and packaging artwork against UDI assignment records, EUDAMED device data, declaration of conformity references, and technical-documentation identifiers.
- When a model, package quantity, sterile state, single-use status, intended purpose, or trade name changes, require regulatory review for UDI-DI impact before the device record is updated.
- For machine-to-machine submission, test against the EUDAMED test/training environment and keep submission logs, schema/version notes, validation errors, corrections, and final registration timestamps.

Sources for this answer:

- [MDCG 2021-19 - UDI integration in QMS](https://health.ec.europa.eu/medical-devices-sector/new-regulations/guidance-mdcg-endorsed-documents-and-other-guidance_en/document/download/64443e95-e1be-4ffd-80f7-9c6a1b0b99b6%5Fen?filename=md%5F2021-19%5Fen.pdf&ref=sorena.io) - MDCG guidance source for integrating UDI assignment, verification, traceability, labels, technical documentation, and EUDAMED data into an organisation's QMS.
- [Commission Implementing Regulation (EU) 2021/2078 on EUDAMED](https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A32021R2078&ref=sorena.io) - Binding source for EUDAMED submission timing, malfunction procedures, test and training websites, machine-to-machine data exchange conditions, and IT security obligations.
- [MDCG 2022-7 - UDI system Q&A](https://health.ec.europa.eu/system/files/2022-05/mdcg_2022-7_en.pdf?ref=sorena.io) - MDCG Q&A source for UDI-DI change examples, UDI carrier issues, UDI and EUDAMED relationships, and UDI use in vigilance and field safety corrective-action reporting.

## Review checklist for an MDR EUDAMED and UDI record

Use this checklist when a device is first registered, when an existing UDI record is changed, when an importer joins the supply chain, or when a label, certificate, technical file, market, or EUDAMED module status changes. The output should be a reconciled device-data pack that quality, regulatory, labelling, supply-chain, and vigilance teams can use without reinterpreting the MDR record.

- Confirm the actor role and SRN for the manufacturer, authorised representative, importer, or system/procedure pack producer before creating or changing a device record.
- Verify Basic UDI-DI grouping and UDI-DI assignment against intended purpose, risk class, model/version, package quantity, sterile status, and single-use status.
- Check that label, IFU, packaging, declaration of conformity, certificate data, technical documentation, and EUDAMED fields use the same device identity and manufacturer name.
- Validate EMDN, UDI/device dataset fields, submission method, access rights, LAA/LUA coverage, and evidence of successful EUDAMED registration or correction.
- Define change triggers for new UDI-DI assessment, EUDAMED update, importer notification, notified-body interaction, vigilance reporting, and PMS/PSUR updates.

Sources for this answer:

- [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 workflow concepts, datasets, EMDN, guidance references, and legacy-device registration context.
- [EUDAMED portal](https://webgate.ec.europa.eu/eudamed?ref=sorena.io) - Commission source for module structure, access model, support links, and operational EUDAMED notices relevant to record review.
- [Regulation (EU) 2017/745 on medical devices](https://eur-lex.europa.eu/eli/reg/2017/745/2023-03-20?ref=sorena.io) - MDR source for the legal duties behind UDI assignment, technical documentation, actor registration, device registration, importer checks, and post-market links.

*Recommended next step*

*Placement: after implementation section*

## Turn MDR UDI data into controlled evidence

Use the EUDAMED and UDI record as a governed device-data pack across regulatory, quality, labelling, supply-chain, vigilance, and post-market workflows.

- [Open Research Copilot](/solutions/research-copilot.md): Answer MDR EUDAMED, UDI, and device-registration questions with cited outputs.
- [Talk through implementation](/contact.md): Review actor records, UDI assignments, label controls, technical-file links, and EUDAMED evidence.

## Primary sources

- [Regulation (EU) 2017/745 on medical devices](https://eur-lex.europa.eu/eli/reg/2017/745/2023-03-20?ref=sorena.io) - MDR source for manufacturer UDI obligations, Article 29 device registration, Article 31 actor registration, importer verification duties, QMS verification of UDI assignments, and technical-documentation linkage.
  - Quote: "ensuring consistency and validity of information"
- [EUDAMED portal](https://webgate.ec.europa.eu/eudamed?ref=sorena.io) - Commission source for EUDAMED purpose, module structure, first-four-module availability statement, EU Login access, and Local Actor Administrator access warning.
  - Quote: "lifecycle of medical devices"
- [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, manufacturer submission of device information, Basic UDI-DI and UDI-DI concept, EMDN, legacy-device registration, and module mandatory-use statement.
  - Quote: "UDI/Device information of all devices"
- [Commission Implementing Regulation (EU) 2021/2078 on EUDAMED](https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A32021R2078&ref=sorena.io) - Binding source for EUDAMED access, support, EMDN use, submission timing, malfunction fallback, testing/training websites, machine-to-machine exchange, and IT security.
  - Quote: "access to and use of Eudamed"
- [MDCG 2022-7 - UDI system Q&A](https://health.ec.europa.eu/system/files/2022-05/mdcg_2022-7_en.pdf?ref=sorena.io) - MDCG Q&A source for UDI-DI change triggers, Basic UDI-DI assignment, UDI labelling, UDI/EUDAMED questions, systems and procedure packs, and configurable devices.
  - Quote: "application and practical implementation"
- [MDCG 2021-19 - UDI integration in QMS](https://health.ec.europa.eu/medical-devices-sector/new-regulations/guidance-mdcg-endorsed-documents-and-other-guidance_en/document/download/64443e95-e1be-4ffd-80f7-9c6a1b0b99b6%5Fen?filename=md%5F2021-19%5Fen.pdf&ref=sorena.io) - MDCG guidance source for integrating UDI into the QMS, technical documentation, labels, declarations, reports, traceability, and EUDAMED data controls.
  - Quote: "Quality Management System"
- [EUDAMED actor module Q&A](https://health.ec.europa.eu/medical-devices-sector/new-regulations/guidance-mdcg-endorsed-documents-and-other-guidance_en/document/download/8e9adf30-71b5-4faf-a8fb-b35ce4804440%5Fen?filename=md%5Fmdcg%5F2021-13%5Fq-a-actor%5Fregistr%5Feudamed%5Fen.pdf&ref=sorena.io) - Commission Q&A source for actor registration, role-specific SRNs, manufacturer-name matching with labels and official documents, importer-manufacturer links, and distributor actor-role limits.
  - Quote: "different and specific SRN for each actor role"

## 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 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.
- [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.


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