UDI and EUDAMED: concrete obligations for manufacturers in 2026

UDI (Unique Device Identification) and EUDAMED are the two pillars of medical device traceability under the MDR and the IVDR. Five years after the first labelling obligations, a decisive step was taken on 28 May 2026: the use of four EUDAMED modules became mandatory. This guide sets out what is required, from when, and for whom.

What is the UDI?

The UDI is defined in Article 27 of the MDR and Article 24 of the IVDR. It has two components:

• UDI-DI (device identifier): identifies a specific model and its packaging level. Each packaging level (unit, box, carton) has its own UDI-DI.
• UDI-PI (production identifier): identifies the production unit, i.e. the lot or serial number, the manufacturing date or the expiry date.

Neither should be confused with the Basic UDI-DI. It groups devices sharing the same intended purpose, risk class and essential design and manufacturing characteristics. It appears in the EU declaration of conformity, certificates, technical documentation and EUDAMED, but never on the label.

The UDI must be:

1. Assigned by one of the four issuing entities designated by the Commission (Implementing Decision (EU) 2019/939): GS1, HIBCC, ICCBBA or IFA
2. Placed on the device label and on all higher levels of packaging, shipping containers excepted
3. Presented in two forms: human-readable (HRI) and machine-readable (AIDC: barcode, DataMatrix, RFID)
4. Registered, with its associated data, in EUDAMED

MDCG 2026-5, published in 2026, recalls that assigning the UDI-DI is the manufacturer's responsibility, including when a distributor or importer is involved in the chain.

Labelling deadlines by class

The UDI carrier became mandatory on labels according to the device class (MDR Article 123, IVDR Article 113). Reusable devices that must carry the UDI on the device itself (direct marking) have two additional years.

Class	UDI carrier on the label	Direct marking of reusable devices
Class III and implantable devices	26 May 2021	26 May 2023
Classes IIa and IIb	26 May 2023	26 May 2025
Class I	26 May 2025	26 May 2027
IVD class D	26 May 2023	—
IVD classes B and C	26 May 2025	—
IVD class A	26 May 2027	—

EUDAMED: six modules, four mandatory since 28 May 2026

EUDAMED, the European database on medical devices, is available at ec.europa.eu/tools/eudamed. It consists of six modules:

1. Actor registration: manufacturers, authorised representatives, importers and system or procedure pack producers register and receive their SRN (single registration number), after validation by the competent authority of their country.
2. UDI and device registration: Basic UDI-DI, UDI-DI, EMDN nomenclature, risk class, characteristics (sterile, contains latex, contains a medicinal substance…).
3. Notified bodies and certificates: certificates issued, suspended or withdrawn, and summaries of safety and performance (SSCP), whose handling is specified by MDCG 2026-4.
4. Clinical investigations and performance studies.
5. Vigilance and post-market surveillance: serious incidents, field safety corrective actions (FSCA), trend reports, PSURs.
6. Market surveillance: exchanges between competent authorities.

Since 28 May 2026, the use of modules 1, 2, 3 and 6 is mandatory. The clinical investigation and vigilance modules will follow once the Commission declares them fully functional. For devices already on the market at that date, Regulation (EU) 2024/1860 provides transitional registration periods.

Common mistakes to avoid

1. Confusing the Basic UDI-DI and the UDI-DI

The Basic UDI-DI is used in the declaration of conformity and certificates; the UDI-DI appears on the label, and each packaging level has its own. All must be registered in EUDAMED.

2. Not creating a new UDI-DI when required

MDR Annex VI, Part C (section 3.9) requires a new UDI-DI whenever one of these elements changes: name or trade name, version or model, "single use" labelling, sterile packaging, need for sterilisation before use, quantity of devices per package, critical warnings or contraindications (for example the presence of latex or DEHP).

3. Choosing your issuing entity too late

GS1 (GS1 DataMatrix) is by far the most widely used in the sector. Membership takes time and has a cost: plan ahead.

4. Forgetting the rest of the chain

Importers and distributors check that the device bears its UDI (MDR Articles 13 and 14). Health institutions store the UDI of the class III implantable devices they receive or supply (Article 27(9)).

5. Not documenting the UDI policy in the QMS

Assigning, managing and updating UDIs must be covered by a procedure in your ISO 13485 quality management system, and the UDI list kept in the technical documentation.

Custom-made and investigational devices

Custom-made devices and devices under investigation are excluded from the UDI system (MDR Article 27(1)). Devices for performance studies benefit from the same exclusion under the IVDR.

Penalties for non-compliance

Penalties are set by each Member State (MDR Article 113). In France, the ANSM can issue formal notices, suspend the placing on the market of a non-compliant device and impose financial penalties.

How MedQara helps you

UDI and EUDAMED rules keep evolving: new MDCG documents, Commission FAQs, the roll-out of the last EUDAMED modules, positions of national authorities. MedQara monitors these publications automatically and tells you, based on your device profile, which ones concern you.

Follow UDI and EUDAMED changes as soon as they are published. Start for free, no credit card required.