EUDAMED in 2026: a practical guide for manufacturers and authorised representatives

EUDAMED — European Database on Medical Devices — is the single European database intended to centralise information on medical devices placed on the European Union market. Announced for 2020, deployed through successive modules, it remains in 2026 a hybrid system: some modules are mandatory, others remain voluntary pending the formal declaration of full functionality.

This guide reviews the real state of the system in 2026 and provides operational instructions for registering, declaring and using EUDAMED.

Why EUDAMED exists

The founding idea: to create a single source of information accessible to competent authorities, healthcare professionals, the general public, and economic operators themselves. Before EUDAMED, each Member State had its own national system. Device recalls, traceability, vigilance — everything was fragmented.

EUDAMED aims at:

1. Public transparency — who manufactures what, which certificates, which incidents
2. Traceability via UDI (Unique Device Identification)
3. Coordination of competent authorities between Member States
4. Administrative simplification — a single registration instead of 27 national ones

The six EUDAMED modules

EUDAMED consists of six independent modules:

Module	Purpose	Status in April 2026
Actors	Registration of manufacturers, authorised representatives, importers, PRRC	Mandatory since end 2021
UDI / Devices	Registration of devices with their unique identifier	Mandatory for registered manufacturers
Notified bodies / Certificates	List of NBs and issued certificates	Operational
Clinical investigations	Clinical studies and performance studies	Voluntary
Vigilance	Incident reports and FSCAs	Voluntary — national reporting in parallel
Market surveillance	Authority activities	Restricted to authorities

Regulation (EU) 2024/1860 established a calendar for the progressive move to mandatory for the vigilance and clinical investigations modules — the horizon is 2027-2028 depending on the module.

Actors module — the first step

Registration and obtaining the SRN

Every economic operator must register in EUDAMED via the Actors module before placing a device on the European market. On completion of registration, the operator receives an SRN (Single Registration Number) — its unique European identifier.

Process:

1. Creation of an EU Login account
2. Actor registration request with supporting documents
3. Validation by the competent authority of the country of establishment (in France: ANSM)
4. Assignment of the SRN

Lead time: validation takes on average 5 to 15 working days in France. Longer if documents are missing.

Documents to provide

• Company statutes (registration extract or equivalent)
• Proof of business address
• PRRC contact details + degree and experience
• For the authorised representative: copy of the mandate signed with the manufacturer

Annual update

The economic operator must verify their information annually in EUDAMED. The PRRC or legal representative formally validates the accuracy of the data.

UDI / Devices module

Understanding the UDI

The UDI consists of two parts:

• UDI-DI (Device Identifier) — fixed identifier of the device, assigned by an issuing entity (GS1, HIBCC, ICCBBA, IFA in Europe)
• UDI-PI (Production Identifier) — variable production identifier (lot number, serial number, expiry date)

The UDI must be:

• On the labelling of the device (and its packaging)
• In human-readable form and as a barcode or data matrix
• For implantable devices and single-use class III: also on the device itself

Registration in EUDAMED

For each UDI-DI, the manufacturer declares a structured set of more than 80 attributes (Annex VI Part B): description, classification, European Nomenclature code (EMDN), references to certificates, presence of specific substances (CMR, endocrine disruptors), etc.

Common mistakes:

• Wrong EMDN classification → rejection or correction request
• Omitting the mention of regulated substances (Annex I 10.4) → incomplete compliance
• Incorrect links to the certificate → registration blocked

Modifications

Any substantial modification of a device (including a new steriliser reference, a new secondary material) requires an update of the EUDAMED registration — within 30 days of the effective modification.

Notified bodies module

This module is mainly consultative for manufacturers — it lists:

• All notified bodies designated under the MDR / IVDR with their precise scope
• Certificates issued (validity, suspensions, withdrawals)
• Scope substitutions

QA/RA tip: before choosing a notified body, check directly in EUDAMED whether its scope genuinely covers your device type. The wordings are precise and an implantable IIb is not equivalent to a non-implantable IIb.

Clinical investigations module (2026 status)

The module is operational but use remains voluntary — parallel reporting to national authorities is still required. Regulation 2024/1860 set indicative dates for the switch to mandatory:

• Q4 2026 — start of the module's audit notification phase
• 2027 — progressive switch to mandatory for new studies

In practice, many sponsors already report in EUDAMED in addition to the national circuit to get ahead.

Vigilance module (2026 status)

Same logic as for clinical investigations — reporting is possible, with dual national + EUDAMED entry in practice.

The EUDAMED reporting format follows the MIR (Manufacturer Incident Report) structure. The legal deadlines remain unchanged:

• 2 days — serious public health threat
• 10 days — death or unforeseen serious deterioration in state of health
• 15 days — other serious incidents

Mistakes to avoid

1. Underestimating the SRN lead time — start 2 months before the actual need
2. Forgetting the annual update — visible non-compliance
3. Confusing Basic UDI-DI and UDI-DI — the Basic UDI-DI groups a family, the UDI-DI identifies a precise reference
4. Poor EMDN selection — the Nomenclature code determines eligibility for several rules
5. Not synchronising with CE marking — a EUDAMED change must be accompanied by an update of the technical documentation and the declaration of conformity

Operational best practices

• Centralise UDI data in a master system (PIM, ERP) with structured export to EUDAMED
• Appoint a EUDAMED owner separate from the PRRC for daily data entry, under PRRC supervision
• Audit registrations annually — compare what is in EUDAMED with the reality of production
• Follow Common Specifications developments — each MDCG or implementing regulation may add fields

Official resources

• EUDAMED portal: ec.europa.eu/tools/eudamed
• MDCG guidance notes on EUDAMED (numbered MDCG 2019-X, MDCG 2021-X)
• European Commission user manuals
• ANSM (French authority) and HMA (Heads of Medicines Agencies) FAQs

Conclusion

EUDAMED in 2026 is more mature than in 2021, but remains a demanding system that requires update discipline and mastery of nomenclatures. For QA/RA teams, the system should be thought of not as an administrative formality, but as an operational reference that structures the regulatory life of devices.

MedQara continuously follows MDCG notes, European Commission communications and EUDAMED module developments — so you are alerted as soon as a change affects your portfolio.

Also read: PRRC: who can be one and what responsibilities · Understanding the MDR regulation · QARA glossary — 60 acronyms