EUDAMED 2026: What Medical Device Manufacturers Must Do Now

What Is EUDAMED?

EUDAMED (European Database on Medical Devices) is the EU's central regulatory database for medical devices and in vitro diagnostic devices. It is established under Article 33 of MDR 2017/745 and Article 30 of IVDR 2017/746 and managed by the European Commission.

EUDAMED is the single source of truth for regulatory information across the entire EU device lifecycle. It stores and interconnects:

• Economic operator (actor) data — manufacturers, authorised representatives, importers
• Device registration data — Basic UDI-DI, device descriptions, intended purposes
• UDI data — all UDI-DI and UDI-PI assignments at device-level
• Notified Body certificates — issued, modified, suspended, withdrawn
• Clinical investigations and performance studies
• Vigilance and post-market surveillance — serious incident reports, field safety corrective actions
• Market surveillance information — national authority actions and decisions

EUDAMED is accessible to regulators, notified bodies, and — for certain modules — the general public. Many modules are now fully live and registration is no longer optional.

EUDAMED Modules: Status and Mandatory Dates

EUDAMED was designed as six interconnected modules, rolled out in phases. The following table shows the current status of each module:

Step 1 — Register as an Economic Operator (Obtain SRN)

The first mandatory step for every manufacturer is to register in EUDAMED as an economic operator and obtain a Single Registration Number (SRN). This applies to:

• Manufacturers established in the EU — register directly
• Non-EU manufacturers — their appointed EU Authorised Representative registers on their behalf and obtains the SRN
• Importers — register separately as importers in EUDAMED

The SRN is referenced on the device label, in technical documentation, in NB applications, and in device registration records. Without an SRN, downstream compliance steps cannot be completed.

Step 2 — Register All Devices (Basic UDI-DI)

Every device placed on the EU market under MDR or IVDR must be registered in EUDAMED at the Basic UDI-DI level. The Basic UDI-DI is the primary identifier that groups device variants sharing the same intended purpose, risk class, essential design, and manufacturing characteristics.

Registration at the Basic UDI-DI level captures:

• Device name and trade name
• MDR/IVDR risk classification and classification rule applied
• Intended purpose
• Whether the device contains a medicinal substance, human/animal tissues, or CMR substances
• Whether the device is single-use, implantable, or for near-patient testing (IVDR)
• Conformity assessment procedure applied
• Reference to the SRN of the manufacturer (and AR for non-EU manufacturers)
• EUDAMED UDI-DI and associated Basic UDI-DI

Step 3 — Register Notified Body Certificates

All Notified Body certificates issued under MDR and IVDR must be registered in EUDAMED by the Notified Body itself. However, manufacturers must ensure that their NB is performing this obligation — the certificate data in EUDAMED must be consistent with the manufacturer's technical documentation and device registration records.

Certificates registered in EUDAMED include:

• EU Type-Examination certificates (Annex IX, X)
• Quality Management System certificates (Annex IX)
• Technical Documentation assessment certificates (Annex X)
• All certificate modifications, suspensions, restrictions, and withdrawals

Manufacturers should verify that their NB has uploaded all relevant certificates and that the EUDAMED record matches the physical certificate — discrepancies can cause issues with market surveillance inspections and product registration.

Step 4 — UDI Assignment and Device-Level Registration

Beyond the Basic UDI-DI, manufacturers must register all UDI-DIs for every device configuration, package size, and labelling variant in EUDAMED. This is sometimes called the "full UDI tree":

All UDI-DIs (unit, pack, higher-level packaging) must be registered in EUDAMED and linked to the Basic UDI-DI. The UDI-PI is not stored centrally in EUDAMED but must appear on the device label or packaging in human-readable and machine-readable (barcode/RFID) form.

Step 5 — Clinical Investigations and Performance Studies

If your device is subject to a clinical investigation under MDR Chapter VI, or a performance study under IVDR Chapter VI, the study must be registered in EUDAMED before it begins. EUDAMED assigns a unique Single Identification Number (SIN) to each registered study.

EUDAMED registration of clinical investigations requires submission of the study summary, protocol synopsis, sponsor information, and intended device details. National competent authority approval processes are linked to EUDAMED study registration, so this step cannot be deferred.

Consequences of Non-Compliance

Failure to meet EUDAMED obligations has direct regulatory and commercial consequences:

• Market access blocked: National competent authorities can prohibit the sale of devices that are not registered in EUDAMED, particularly where the SRN is absent from the label.
• CE marking effectively invalid: A device without proper EUDAMED registration — including linked NB certificate records — may not be considered compliant for market surveillance purposes, undermining the CE mark.
• NB certificate issues: Notified Bodies are required to verify EUDAMED registration status during surveillance audits and certificate renewal. Gaps in EUDAMED data can delay or block re-certification.
• Importer and distributor exposure: EU importers and distributors who verify compliance before placing products on the market may refuse to handle devices lacking EUDAMED registration evidence.
• Enforcement action: National authorities have the legal basis to issue corrective action requirements, device recalls, or administrative fines for EUDAMED non-compliance under MDR/IVDR enforcement provisions.

Integration with MDR and IVDR Obligations

EUDAMED is not a standalone obligation — it is the operational backbone of MDR and IVDR compliance. Key intersections include:

• EU Authorised Representative: The AR is registered in EUDAMED and linked to the manufacturer. Non-EU manufacturers cannot register devices without a registered AR. See our MDR Authorised Representative guide.
• Post-Market Surveillance: PSUR (Periodic Safety Update Report) submissions for Class IIa and above (MDR) and Class B and above (IVDR) are linked to EUDAMED device registration records.
• Vigilance Reporting: Serious incident reports and FSCAs are filed through EUDAMED, cross-referenced to the registered device (UDI-DI) and manufacturer (SRN).
• Technical Documentation: EUDAMED records must be consistent with technical documentation — same device descriptions, intended purposes, and classification rationale.
• Labels: MDR Article 10(8) requires the SRN and UDI to appear on the device label. Devices not yet labelled with the SRN must be updated at the next labelling revision.

EUDAMED 2026 Action Checklist

Practical Considerations for Non-EU Manufacturers

Non-EU manufacturers face particular challenges with EUDAMED because they cannot register directly — all EU-facing EUDAMED interactions must be conducted through or coordinated with their EU Authorised Representative. Critical points:

• The AR registers the manufacturer as an economic operator and obtains the SRN — this SRN must appear on the device label
• The AR must have system access (EUDAMED account) and the technical capability to manage device registrations — verify this before appointing an AR
• All device registration data must be provided to the AR in the correct format — establish a data governance process
• EUDAMED data must be kept up to date — any change to intended purpose, classification, configuration, or NB certificate must be reflected promptly
• If you change your EU AR, the EUDAMED records must be updated immediately — gaps in AR coverage can cause compliance breaks

Frequently Asked Questions