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• Notified Body certificates — issued, modified, suspended, withdrawn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 information — the general public. Mandatory use currently applies to four of the six modules.

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:

Module	Scope	Status (2026)
Actor Registration	Economic operators — manufacturers, ARs, importers. Issues the SRN.	Mandatory since 28 May 2026
UDI / Device Registration	Basic UDI-DI and device registration data.	Mandatory since 28 May 2026; transition rules apply
Notified Bodies & Certificates	Certificates issued, amended, suspended, reinstated, withdrawn or refused by NBs.	Mandatory since 28 May 2026; transition rules apply
Clinical Investigations & Performance Studies	Clinical investigations under MDR and performance studies under IVDR.	Under analysis — not yet mandatory in EUDAMED
Vigilance & Post-Market Surveillance	Serious incidents, trend reports, FSCAs and related PMS data.	In development — not yet mandatory in EUDAMED
Market Surveillance	National authority decisions, withdrawals and restrictions.	Mandatory since 28 May 2026 for authorities and the Commission

Source: European Commission EUDAMED overview. For devices already placed on the market before mandatory use, see the Commission's device-registration transition infographic.

Certificate transition is separate: new MDR/IVDR certificates issued from 28 May 2026 must be registered in EUDAMED, while applicable certificates issued before mandatory use generally have a registration deadline of 28 May 2027. See the Commission's certificates and devices transition timeline.

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 — submit their own actor registration request after appointing an EU Authorised Representative; the AR verifies the request and mandate linkage
• Importers — register separately as importers in EUDAMED

The SRN is used in EUDAMED records and must be stated when applying to a notified body for conformity assessment. It identifies the economic operator across the system; it is not a general MDR/IVDR labelling element.

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

Manufacturers must submit the required UDI/device information for devices placed on the EU market under MDR or IVDR. Devices first placed on the market from 28 May 2026 must be registered before placement; applicable legacy and Regulation devices first placed before that date generally must be registered by 28 November 2026. The Basic UDI-DI identifies a device family and links the device data to certificates and technical documentation.

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 — Use Current National Channels for Studies and Vigilance

The EUDAMED Clinical Investigations and Performance Studies module is still under analysis, and the Vigilance and Post-Market Surveillance module is still in development. They are not yet mandatory EUDAMED channels. Sponsors and manufacturers must continue following the currently applicable national and EU submission arrangements until the Commission declares each module functional and its mandatory-use date is reached.

Consequences of Non-Compliance

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

• Corrective measures: Competent authorities may require the economic operator to correct missing or inaccurate registration data and can use their MDR/IVDR enforcement powers where non-compliance continues.
• Market-access disruption: Missing mandatory registrations can delay notified-body, importer, distributor or authority checks, even though registration alone does not determine whether a CE mark is valid.
• 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: Maintain the MDR/IVDR PMS and PSUR processes, but use the currently applicable submission channels until the EUDAMED Vigilance and PMS module becomes mandatory.
• Vigilance Reporting: Continue reporting serious incidents and FSCAs through the channels currently required by the relevant competent authorities.
• Technical Documentation: EUDAMED records must be consistent with technical documentation — same device descriptions, intended purposes, and classification rationale.
• Labels: Apply UDI labelling according to the MDR/IVDR class-based timelines and Annex VI requirements. The SRN is not a general label element.

EUDAMED 2026 Action Checklist

Practical Considerations for Non-EU Manufacturers

Non-EU manufacturers register as actors in their own capacity, but they must first appoint an EU Authorised Representative. The AR verifies the manufacturer's registration request and the mandate relationship. Critical points:

• The manufacturer submits its actor request; the AR verifies the relevant mandate information before competent-authority validation
• Agree who will prepare, submit and maintain device data and document that responsibility in the mandate and operating procedure
• Maintain consistent manufacturer, AR, SRN, Basic UDI-DI and certificate data across EUDAMED and technical documentation
• 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