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. Two years after the first obligations, many manufacturers still have gaps in their compliance — often through a lack of clarity about what is required, when, and how. This guide answers those questions concretely.

What is the UDI?

The UDI is a unique identification system for medical devices, based on two components:

• UDI-DI (Device Identifier) — identifies the device model/version. It changes with every significant modification of the device (change of design, formulation, packaging, etc.)
• UDI-PI (Production Identifier) — identifies the production unit (lot number, serial number, manufacturing date, expiry date)

The UDI must be:

1. Assigned via an accredited issuing entity (GS1, HIBCC, ICCBBA or IFA)
2. Applied to the device label and to all higher levels of packaging
3. Integrated in a human-readable format (text) and an AIDC format (barcode, DataMatrix, RFID)
4. Registered in the EUDAMED UDI database

UDI deadlines by class

Class	UDI-on-label obligation date	EUDAMED obligation date
Class III	26 May 2021	26 May 2021
Class IIb	26 May 2023	26 May 2023
Class IIa	26 May 2025	26 May 2025
Class I	26 May 2027	26 May 2027
IVD class D	26 May 2023	26 May 2023
IVD classes B and C	26 May 2025	26 May 2025
IVD class A	26 May 2027	26 May 2027

⚠️ Reusable devices have specific obligations: the UDI-PI must be applied to the device itself (not only the packaging), unless a justified exemption applies under Annex VI Part C of the MDR.

The 6 EUDAMED modules

EUDAMED (European Database on Medical Devices) is the central European traceability platform. It consists of 6 interconnected modules:

Module 1 — Actor registration (ACTOR)

Mandatory for: all manufacturers, European authorised representatives (AR), importers.

You must create an SRN (Single Registration Number) account on EUDAMED before any device registration. The SRN is assigned by the competent authority of your country (in France: ANSM).

How to obtain your SRN:

1. Create an account on EUDAMED (eudamed.ec.europa.eu)
2. Submit the request to ANSM via the EUDAMED portal
3. ANSM validates and assigns the SRN (lead time: a few weeks)

Module 2 — UDI / Device registration (UDI-DI)

Mandatory according to the deadlines in the table above.

For each device, you register:

• The Basic UDI-DI and the packaging UDI-DIs
• The device description, the EMDN codes (European nomenclature)
• The device characteristics (sterile, contains latex, contains a medicinal substance, etc.)
• The MDR/IVDR classification
• The notified body certificate number (if applicable)

Module 3 — Device registration (DEVICE)

Complements the UDI module with additional information: linked clinical investigations, certificates, declarations of conformity.

Module 4 — Clinical investigations

Registration of clinical investigations conducted in the EU.

Module 5 — Vigilance

Notification of serious incidents and field safety corrective actions (FSCA).

Module 6 — Market surveillance

Access restricted to competent authorities.

Common mistakes to avoid

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

The Basic UDI-DI identifies the device itself. Each packaging level (unit box, box of 10, carton) has its own UDI-DI. All must be registered in EUDAMED.

2. Not updating the UDI-DI on modifications

Any "significant" modification of the device or its labelling requires a new UDI-DI. The definition of "significant" is specified in Implementing Regulation 2021/2226.

3. Choosing your issuing entity too late

GS1, HIBCC, ICCBBA and IFA are the four accredited systems. GS1 (EAN barcodes / GS1 DataMatrix) is by far the most used in the medical sector. Joining GS1 takes time and has a cost — plan ahead.

4. Forgetting reimbursable devices

In France, devices listed on the LPP (list of reimbursable products and services) have additional UDI obligations linked to the health insurance BOSS system.

5. Not documenting the UDI policy in the QMS

The assignment, management and updating of UDIs must be covered by a documented procedure in your ISO 13485 quality management system.

The special case of custom-made and made-to-order devices

Custom-made devices and certain made-to-order devices have partial UDI exemptions. They are not subject to the obligation to register in the EUDAMED UDI database, but remain subject to the obligation to apply the UDI on the label.

Penalties for non-compliance

Penalties are defined at national level. In France:

• Formal notice from ANSM with a compliance deadline
• Suspension of placing on the market for unregistered devices
• Administrative fines (amounts set by decree)

ANSM has been conducting active checks since 2024, in particular on class IIa and IIb devices whose obligation is recent.

How MedQara helps you

UDI/EUDAMED regulation evolves constantly: new Commission FAQs, EUDAMED module updates, national authority decisions on borderline cases. MedQara automatically monitors:

• Updates to the UDI implementing regulation
• New EUDAMED FAQs published by the Commission
• ANSM communications on the application of UDI in France
• The go-live of new EUDAMED modules

Each alert is analyzed by our AI to tell you whether it concerns you, according to your device profile.

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