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Regulatory & Compliance

EUDAMED.

The central European database for medical devices and IVDs. We guide you through every step of the process—from Actor registration and UDI maintenance to vigilance reporting—ensuring compliance with deadlines and audit readiness.

Registration process in a central European database

What is EUDAMED? EUDAMED (European Database on Medical Devices) is the central EU database for medical devices and IVDs, as required by Article 33 of the MDR (EU 2017/745). It comprises six modules: Actor Registration, UDI/Device Registration, Notified Bodies, Clinical Trials, Performance Studies, and Vigilance. Starting May 28, 2026, Modules 4–6 will become fully mandatory.

What EUDAMED requirements must manufacturers meet by May 2026?

The full activation of EUDAMED Modules 4–6 on May 28, 2026, poses specific compliance risks for manufacturers:

  • Without a valid SRN (Single Registration Number) from Module 1, products cannot be registered and vigilance reports cannot be submitted.
  • UDI registration (Basic UDI-DI + UDI-DI) must be consistent across labeling, EUDAMED, and internal documentation—any discrepancies are considered a documentation deficiency.
  • Starting in May 2026, serious adverse events and FSCA reports must be submitted exclusively via EUDAMED Module 6—no longer bilaterally via email.
  • PSURs and PMSRs must be structured in a way that allows them to be uploaded to EUDAMED—the entire PMS workflow must be adapted.
Have you completed your actor registration and configured your vigilance workflow to be EUDAMED-compatible?
Specialist reviews Eudamed registration forms

Our EUDAMED consulting services.

From initial SRN registration to ongoing vigilance reporting—we handle all aspects of EUDAMED compliance.

Actor Registration & SRN
Complete application process for the Single Registration Number for manufacturers, authorized representatives, importers, and distributors. Coordination with the BfArM and national authorities.
UDI Registration & Data Maintenance
Correct mapping of Basic UDI-DI and UDI-DI, linking to NB certificates, and ongoing data maintenance for product changes. Collaboration with GS1, HIBCC, and ICCBBA.
Pharmacovigilance Workflow (Module 6)
Establishment of EUDAMED-compliant reporting processes for SAR, FSCA, PSUR, and PMSR. Integration into existing eQMS systems and definition of internal responsibilities.
EUDAMED Gap Analysis & Readiness
A systematic review of your current EUDAMED status across all six modules. A prioritized action plan with deadline tracking for the May 2026 deadlines.

How does an EUDAMED project with ENTOURAGE work?

Structured in 5 phases—from the initial assessment to ongoing reporting.

01

Status Check

Analysis: Is an SRN available? Is the UDI complete? Have vigilance processes been defined? Has the product portfolio been documented?

02

Registration

Actor registration (SRN) and UDI registration for the entire product portfolio.

03

Workflow Setup

Configure vigilance and PMS processes to be EUDAMED-compatible. eQMS integration.

04

Test run

Simulation of a vigilance report and a PSUR upload. Final revisions before the deadline.

05

Ongoing reporting

Ongoing support for data maintenance, pharmacovigilance reports, and PSUR/PMSR cycles.

Attorney at Law
“EUDAMED is not just a database—it is the central proof of compliance for regulatory authorities. Anyone who is not registered by May 28, 2026, will no longer be able to submit vigilance reports and risks losing market access.”
Regulatory Affairs Team, ENTOURAGE

Frequently Asked Questions About EUDAMED.

What is EUDAMED, and who needs to register?
EUDAMED is the European database for medical devices and IVDs, as provided for in Article 33 of the MDR and Article 30 of the IVDR. Manufacturers, authorized representatives, importers, and distributors who place medical devices or IVDs on the EU market are required to register.
What happens if the EUDAMED registration is not completed?
Without a valid SRN, products cannot be placed on the market in compliance with regulations. Starting in May 2026, vigilance reports and PMS reports cannot be submitted without EUDAMED access—which may result in regulatory action, including market withdrawal.
What is the difference between Basic UDI-DI, UDI-DI, and UDI-PI?
The Basic UDI-DI identifies a device group (primary key in EUDAMED). The UDI-DI identifies the specific commercial product and must appear on the label. The UDI-PI contains variable data such as batch number and expiration date.
What are the deadlines for PSURs and PMSRs in EUDAMED?
PSURs for Class IIb/III devices must be submitted at least every two years; for Class III devices and implants, annually. PMSRs for Class I/IIa devices must be submitted at least every five years. Starting in May 2026, submission via EUDAMED will be mandatory.
How long does the full EUDAMED registration process take?
Actor registration (SRN): 2–5 business days. UDI registration: individual products within hours; complex portfolios 2–8 weeks. Vigilance workflow setup: 1–3 weeks, depending on eQMS integration.
How much does EUDAMED consulting cost?
A gap analysis takes 2–5 consultant days. Full implementation support takes between 5 and 20 consultant days, depending on the size of the portfolio. If the deadline is approaching, more intensive work is required.

Additional expertise in regulatory affairs.

Expertise

MDR Consulting

Implementing EU Regulation 2017/745: Technical Documentation, Clinical Evaluation, and Post-Market Surveillance.

 Expertise

Post-Market Surveillance

PMS plans and PSURs as the basis for EUDAMED Module 6 reporting.

 Expertise

IVDR Readiness

EUDAMED obligations for IVD manufacturers under Regulation (EU) 2017/746.

Ensure EUDAMED compliance before the deadline.

Starting in May 2026, it will no longer be possible to submit vigilance reports without EUDAMED. We will ensure that your registration and workflows are up to date by the deadline.

Ensure compliance with EUDAMED.

Describe your product portfolio—we’ll review your EUDAMED status and create a registration plan.