Mandatory EUDAMED Use from 2026: What Has Changed and How We Can Help

Mandatory EUDAMED Use from 2026: What Has Changed and How We Can Help

Published on 09 June, 2026 by Evangelos MantadakisEvangelos Mantadakis

EUDAMED (European Database on Medical Devices) is no longer an optional pilot platform. Following the announcement from Greece's National Organization for Medicines (EOF), use of the first four modules of the platform is now mandatory for economic operators active in the medical device sector.

In this article, we summarize what has changed, who is affected, and how QC Analytics can support you in completing your registrations.

What Is EUDAMED?

EUDAMED is the central European database established under MDR (EU) 2017/745 and IVDR (EU) 2017/746. Its purpose is to provide a comprehensive overview of the lifecycle of medical devices in the European Union, strengthening transparency, traceability, and coordination between member states.

Part of the platform's data is publicly available to citizens, patients, healthcare professionals, and other stakeholders. The platform is accessible via the official EUDAMED system of the European Commission.

In practice, on the public version of the platform you can search for and view, among other things:

  • Economic operators (Actors): manufacturers, importers, authorized representatives, and other registered actors, together with their SRN / Actor ID and basic identity details
  • Medical devices and UDI: product information, Basic UDI-DI, category/risk class, labeling details, and data related to traceability when placing devices on the market
  • EMDN nomenclature: the European Medical Device Nomenclature used when registering products
  • Notified Bodies and certificates: details on issued, suspended, reinstated, withdrawn, or refused certificates, as well as restrictions that have been imposed
  • Summaries of safety and clinical performance (SSCP): for product categories where publication of such summaries is required

The EOF Announcement: What Is Now Mandatory?

Under the EOF announcement, use of the following four EUDAMED modules has been mandatory since 28 May 2026:

  1. Actor registration — Registration of manufacturers, importers, authorized representatives, or other relevant actors, and issuance of a Single Registration Number (SRN)
  2. UDI/Devices registration — Registration of medical devices and UDI-DI / Basic UDI-DI codes before they are placed on the European market
  3. Notified Bodies and Certificates — Registration of EU conformity certificates issued by Notified Bodies (e.g. type, design, quality, or production assessment), as well as their amendments, suspensions, withdrawals, or refusals
  4. Market Surveillance — Exchange of information and data related to market surveillance

The obligation mainly applies to:

  • Manufacturers of medical devices
  • Authorized Representatives
  • Importers

For new products, registration in EUDAMED is a prerequisite before they can be placed on the EU market. For products already on the market, immediate updating and compliance with the mandatory modules is required.

Why EUDAMED Registration Is Critical

Registration in EUDAMED is not merely a formal procedure. It is a fundamental requirement for the lawful and safe distribution of medical devices across the European Union.

Incomplete or incorrect registration can lead to:

  • delays in market access
  • rejections or correction requests from the competent authority
  • inconsistency between national (e.g. EOF/GreMDIS) and European processes
  • increased regulatory risk during inspections or market surveillance checks

How We Can Help with EUDAMED Registrations

At QC Analytics, we support organizations across the full regulatory registration cycle — from EOF and the national GreMDIS registry to EUDAMED and UDI/GS1 implementation. Our approach focuses on practical compliance, not only on formal data submission. Specifically, we can help you with:

  • EUDAMED requirements analysis: interpreting requirements based on your role (manufacturer, authorized representative, or importer) and your products' category/risk class
  • Data completeness review: assessing technical files, UDI, certificates, actor details, and related MDR/IVDR documentation before submission
  • Correct platform registration: guidance or managed registration with emphasis on data consistency, accuracy, and regulatory compliance
  • Communication with EOF: support in resolving obstacles in national and European registration processes
  • Corrections and amendments: guidance on product or actor changes and data updates across the product lifecycle
  • EUDAMED ID / SRN issuance: completing actor registration and obtaining a unique EUDAMED ID or SRN (Single Registration Number)
  • UDI and GS1 implementation: assignment of GTIN (UDI-DI) and Basic UDI-DI (GMN), labeling requirements, data structuring, and UDI integration into your internal systems

Our Approach

  • Tailored application: We adapt EU requirements to your products and your company's role.
  • Value-added reviews: We review your product files and processes so registrations are based on sound documentation.
  • Preparation for real scrutiny: We take into account how the competent authority evaluates submissions to reduce the risk of rejections or delays.

We have experience supporting manufacturers, European representatives, and importers, with a focus on aligning national (EOF) and European (EUDAMED) processes.

Next Steps

The 28 May 2026 deadline for mandatory use of EUDAMED has already passed. If you have not yet completed actor registration, product registration, or UDI data alignment, immediate action to achieve compliance is essential.

For details on our services, see our EOF, EUDAMED, GS1 page. For a quote or guidance on your registrations, contact us.