EU MDR UDI and EUDAMED

Start with the manufacturer and actor record. MDR Article 31 requires manufacturers, authorised representatives, and importers to submit actor information before placing non-custom-made devices on the market, unless already registered. After competent-authority verification, the electronic system issues the Single Registration Number (SRN).

Then map the device identifiers. MDR Article 27 describes the UDI system as a UDI-DI, which is specific to a manufacturer and device, plus a UDI-PI, which identifies the production unit and, where applicable, packaged devices. Article 29 requires the manufacturer to assign a Basic UDI-DI before placing a non-custom-made device on the market and to provide it with core data elements to the UDI database.

Treat the Basic UDI-DI as the regulatory family key, not the label code. MDCG 2022-7 describes it as the main key in the database and relevant documentation, including product certificate, declaration of conformity, technical documentation, and SSCP, for devices with the same intended purpose, risk class, and essential design and manufacturing characteristics.

The UDI carrier must not be managed separately from the technical file. MDR Article 27 requires UDI carriers on the device label and all higher levels of packaging, excluding shipping containers. The same article requires the Basic UDI-DI on the EU declaration of conformity and an up-to-date list of assigned UDIs in the technical documentation.

For software, Annex VI Part C gives separate UDI rules. A new UDI-DI is required when a software modification changes original performance, safety, intended use, or data interpretation; minor revisions require a new UDI-PI rather than a new UDI-DI. The UDI must be available on an accessible screen or through an API where there is no user interface.

For systems and procedure packs, Annex VI Part C assigns UDI responsibility to the person referred to in Article 22, requires the pack UDI carrier outside the packaging as a general rule, and preserves separate UDI requirements for device contents unless an exemption applies.

EUDAMED has six modules: actor registration, UDI/device registration, notified bodies and certificates, clinical investigations and performance studies, vigilance and post-market surveillance, and market surveillance. The Commission EUDAMED portal states that the first four modules are mandatory from 28 May 2026 and identifies Actor, UDI/devices, NBs and Certificates, and Market Surveillance for competent authorities and the European Commission as those modules.

The actor-registration page states that every economic operator in the medical devices sector, including EU and non-EU manufacturers, authorised representatives, system or procedure pack producers, and importers, must register before placing devices or systems/procedure packs on the EU market. The same page states that all actors upload a signed declaration on information-security responsibilities, and non-EU manufacturers need an active authorised representative and mandate summary document.

The UDI/Device registration page states that manufacturers submit UDI/Device information for devices they place on the EU market. Voluntary entry began in October 2021, and the module became mandatory on 28 May 2026 after Commission Decision (EU) 2025/2371 declared it functional and Regulation (EU) 2024/1860 supplied the transition rule. The Vigilance and Post-Market Surveillance module remains in development, and the Clinical Investigations and Performance Studies module remains under analysis.

UDI and EUDAMED records need explicit change governance. MDCG 2022-7 states that a new UDI-DI is required when a change could lead to device misidentification or ambiguity in traceability, including changes to name or trade name, device version or model, single-use status, sterile packaging, need for sterilisation before use, package quantity, critical warnings or contraindications, and certain CMR or endocrine-disruptor information.

The same guidance says a new UDI-DI would be required when a substance-based device has a formulation change or an extension of claims such as an additional medical purpose. For reprocessed single-use devices under MDR Article 17(2), MDCG 2022-7 says the reprocessor is considered the manufacturer and must assign a new Basic UDI-DI and UDI; reprocessing within a health institution under Article 17(3) does not require a new UDI under that guidance.

Branding agreements do not transfer UDI assignment to a distributor. MDCG 2026-5 says the manufacturer assigns every UDI-DI, including separate UDI-DIs for the same device sold under different trade names, and those identifiers must remain linked to the manufacturer. A third party may perform practical tasks on the manufacturer's behalf, but the manufacturer retains legal responsibility.

MDR Article 10 also makes UDI verification part of the manufacturer's quality management system: procedures must verify UDI assignments and ensure consistency and validity of information provided under Article 29. That makes UDI impact review part of change control, not a clerical update after release.

A useful UDI/EUDAMED evidence pack shows the chain from product definition to public registration. It should let a reviewer trace the marketed device from intended purpose, risk class, model/version, packaging, label, IFU, certificate, declaration, Basic UDI-DI, UDI-DI, UDI carrier, EUDAMED record, and market status without reconstructing the project history.

Keep EUDAMED governance evidence separate from but linked to the technical documentation. The controlled file should include who owns actor access, who approves device data, which source fields populate EUDAMED, when changes trigger new identifiers, and how EUDAMED updates are reconciled with PMS, vigilance, field safety corrective action, certificates, and label changes.

Do not rely on a registration confirmation alone. The MDR and MDCG sources point to a broader evidence model: technical documentation must contain assigned UDIs, declarations must show Basic UDI-DI, Article 29 information must stay current, and UDI changes must remain traceable through QMS change control.