--- title: "UDI and EUDAMED" canonical_url: "https://www.sorena.io/artifacts/eu/medical-device-regulation/udi-and-eudamed" source_url: "https://www.sorena.io/artifacts/eu/medical-device-regulation/udi-and-eudamed" author: "Sorena AI" description: "A practical MDR UDI and EUDAMED guide: Basic UDI-DI, UDI-DI, UDI-PI, actor registration and SRN, Article 29 device registration." published_at: "2026-02-22" updated_at: "2026-02-22" keywords: - "EU MDR UDI" - "EUDAMED" - "Basic UDI-DI" - "UDI-DI UDI-PI" - "UDI carrier placement" - "direct marking UDI" - "actor registration EUDAMED SRN" - "EUDAMED device registration UDI database" - "EUDAMED modules actors devices certificates vigilance" - "UDI integration QMS" - "software UDI assignment MDCG 2018-5" - "basic UDI-DI changes MDCG 2018-1" - "EU MDR" - "UDI" - "Actor registration" - "Device registration" - "Traceability" --- **[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) --- # UDI and EUDAMED A practical MDR UDI and EUDAMED guide: Basic UDI-DI, UDI-DI, UDI-PI, actor registration and SRN, Article 29 device registration. *UDI/EUDAMED* *EU* ## EU Medical Device Regulation (MDR) 2017/745 UDI and EUDAMED Traceability and registration you can operationalise. This guide focuses on execution: Basic UDI-DI strategy, SRN governance, Article 29 and 31 registration, software UDI rules, importer checks, and the 28 May 2026 mandatory-use milestone for the first four EUDAMED modules. UDI and EUDAMED touch product, ops, and compliance: label artwork, packaging, variant control, master data, and reporting workflows. Teams often fail here because UDI/EUDAMED is treated as a late-stage registration task Instead, treat it as a traceability operating system integrated into your QMS and release processes. ## UDI basics (what you must define before implementation works) UDI is a traceability system, not just a label field. The real work is deciding the device family, variant boundaries, packaging hierarchy, and change triggers that determine when identifiers must change. Control: write one UDI strategy memo per device family and keep it linked to change control, label approval, software release management, and complaint handling. - Assign a Basic UDI-DI before placing a device, other than a custom-made device, on the market. Use it as the family-level anchor for device records, certificates, declarations, PSUR grouping, and technical documentation. - Define when UDI-DI and UDI-PI change, including packaging, label, version, and software-release triggers where relevant. - Remember the scope limits: the MDR UDI system applies to devices other than custom-made and investigational devices. - For software, align UDI assignment with the released version and the actual distribution model so app-store, cloud, and on-premise releases can still be traced. - Connect UDI to complaints, vigilance, CAPA, and returned-product analysis so the same identifier set is used across the lifecycle. ## EUDAMED onboarding: Article 31 actor registration and SRN governance Actor registration is the first dependency. Manufacturers, authorised representatives, and importers in Article 31 scope need the right legal-entity setup and SRN governance before the rest of EUDAMED can stay clean. Control: create an EUDAMED roles and delegation SOP with named access approvers, backup owners, and periodic access review. - Before placing a device, other than a custom-made device, on the market, manufacturers, authorised representatives, and importers must register the required actor information and obtain the SRN. - If a notified body is required, the Article 31 information needs to be in the system before applying to that notified body. - Non-EU manufacturers need an active authorised representative and should control the mandate-summary evidence used for actor registration. - As from 28 May 2026, the Actor Registration module is mandatory to use under the gradual EUDAMED rollout. - Store SRNs in controlled master data and reuse them consistently in notified-body applications, device registration, vigilance records, and internal procedures. ## Article 29 device registration and importer verification Device registration becomes painful when the technical file, label, ERP master data, and EUDAMED entry disagree. Treat Article 29 registration as a master-data-governance process inside the QMS. Control: no new variant, label update, or software release should be approved until the registration impact has been assessed and documented. - Before placing a device, other than a custom-made device, on the market, the manufacturer must enter or verify the Article 29 device information in EUDAMED and keep it updated. - Importers have two linked checks: within two weeks of placing a device on the market they verify that the manufacturer or authorised representative provided the required device information, and they add their own details in accordance with Article 31. - Article 10(9)(h) also pulls UDI into the QMS: the manufacturer must verify UDI assignments and ensure consistency and validity of the information provided under Article 29. - As from 28 May 2026, the first four EUDAMED modules become mandatory to use, so actor, UDI and device, certificate, and market-surveillance records need production-grade data quality. - Keep an interim plan for modules that are not yet mandatory, especially where vigilance or clinical-investigation records still need parallel handling. ## Minimum evidence pack for audits and incident response The goal is fast, credible answers to basic questions: which device was placed on the market, under which identifiers, by which actor, and what changed since the last approved release. Attach links to these records in the technical documentation and the QMS procedures so retrieval does not depend on one person. - UDI strategy memo and mapping tables for Basic UDI-DI, UDI-DI, packaging levels, variants, and software releases. - Article 31 actor-registration file: SRN evidence, declaration on information-security responsibilities, mandate summary where relevant, and access-governance records. - Article 29 device-registration file: approved submission set, proof of submission, verification checks, correction log, and date-stamped change history. - Labeling and artwork approvals that prove the UDI carrier on the released label matches the registered data. - Periodic data-quality audits and CAPA records for mismatches between label, technical file, ERP or PLM, and EUDAMED. *Recommended next step* *Placement: after the template, evidence, or documentation block* ## Keep EU Medical Device Regulation (MDR) 2017/745 UDI and EUDAMED in one governed evidence system SSOT can take EU Medical Device Regulation (MDR) 2017/745 UDI and EUDAMED from reusing this material inside a governed evidence system to a reusable workflow inside Sorena. Teams working on EU Medical Device Regulation (MDR) 2017/745 can keep owners, evidence, and next steps aligned without copying this guide into separate documents. - [Open SSOT for EU Medical Device Regulation (MDR) 2017/745 UDI and EUDAMED](/solutions/ssot.md): Start from EU Medical Device Regulation (MDR) 2017/745 UDI and EUDAMED and keep documents, evidence, and control records in one governed system. - [Talk through EU Medical Device Regulation (MDR) 2017/745](/contact.md): Review your current process, evidence gaps, and next steps for EU Medical Device Regulation (MDR) 2017/745 UDI and EUDAMED. ## Primary sources - [Regulation (EU) 2017/745 - Medical Device Regulation (MDR) (EUR-Lex)](https://eur-lex.europa.eu/eli/reg/2017/745/oj/eng?ref=sorena.io) - Primary legal text for Articles 27, 29, and 31, importer verification, and UDI scope limits. - [Medical Devices - EUDAMED overview (European Commission)](https://health.ec.europa.eu/medical-devices-eudamed_en?ref=sorena.io) - Official EUDAMED page covering module status and the mandatory-use milestone for the first four modules from 28 May 2026. - [Actor registration module (European Commission)](https://health.ec.europa.eu/medical-devices-eudamed/actor-registration-module_en?ref=sorena.io) - Official actor-registration page for SRN workflow, required documents, and the Actor module mandatory-use milestone from 28 May 2026. - [Regulation (EU) 2024/1860 (EUR-Lex)](https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32024R1860&ref=sorena.io) - Regulation establishing the gradual EUDAMED rollout framework. - [MDCG 2018-1 Rev.4 - Basic UDI-DI and changes to UDI-DI (European Commission)](https://health.ec.europa.eu/document/download/cb1bf6e5-3972-4b3a-82d9-c5946738b2a5_en?filename=md_mdcg_2018-1_guidance_udi-di_en.pdf&ref=sorena.io) - Operational guidance on Basic UDI-DI and when UDI identifiers should change. - [MDCG 2018-5 - UDI assignment to medical device software (European Commission)](https://health.ec.europa.eu/document/download/4b5b2942-aaab-4b78-a188-df111a8d903e_en?filename=md_mdcg_2018_5_software_en.pdf&ref=sorena.io) - Guidance on UDI assignment for software devices and software releases. ## Related Topic Guides - [Applicability Test | EU Medical Device Regulation (MDR) 2017/745 | Is it a Medical Device? Annex XVI? Software Rule 11?](/artifacts/eu/medical-device-regulation/applicability-test.md): A step-by-step MDR applicability test for Regulation (EU) 2017/745: confirm intended purpose, device definition and exclusions. - [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. --- [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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