UDI/EUDAMEDEU

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.

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Author

Sorena AI

Published

Feb 22, 2026

Updated

Feb 22, 2026

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Publication metadata

Sorena AI

Published Feb 22, 2026

Updated Feb 22, 2026

Overview

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.

Section 1

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.

Section 2

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.

Section 3

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.

Section 4

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.

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