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EU Guide: EUDAMED overview and how to register your company

Medical devices regulation

EUDAMED – a unique tool for Medical Device Registration in the EU

EUDAMED stands for the “European Database on Medical Devices”. It is the equivalent of the US public government databases (FDA’s database), which contains all registered Establishments, device listings, 510(k)s and pre-market approvals, adverse events/recalls, clinical investigation data, etc. EUDAMED will allow to manage the tremendous amount of information related to manufacturers, authorized representatives, importers, product details, safety reports, and clinical trials. EUDAMED is the keystone of EU’s regulatory framework for medical devices: the Medical Devices Regulation (MDR 2017/745) and the In Vitro Diagnostic Medical Devices Regulation (IVDR 2017/746). 

EUDAMED’s primary purpose is to improve market transparency and oversight in medical device field by providing comprehensive repository of information on medical devices and their manufacturers, representatives or importers active within the EU. More than just repository, EUDAMED also integrates many processes related to medical devices lifecycle : product registration, post-market surveillance, vigilance, clinical investigations, and certification activities.

Therefore, EUDAMED is a legal requirement for medical devices manufacturer and authorized representatives.

EUDAMED registration process

The EUDAMED registration process involves several steps. A manufacturer or the authorized representative applies for Single Registration Number (SRN). This SRN is unique identifier used across the EU to identify the manufacturer in the EUDAMED system. 

Once the SRN is assigned, Manufacturers are required to provide detailed information about their devices: product’s unique devices identification (UDI), details of clinical investigation conformity assessment procedures, certificates issued, incidents and corrective actions, details of any recalls or withdrawals, etc. This data will be accessible to competent authorities, notified bodies, economic operators, sponsors, and the public, as appropriate.

Detailled steps:

1- First, create a new EU log-in account here: EUDAMED restricted site

2- Then, submit your company registration, following the Actor Registration steps.

The following Economic Operators must register in EUDAMED as Actors:

  • Manufacturers (both EU and non-EU)
  • System/Procedure Pack Producers (both EU and non-EU)
  • EU Authorized Representatives
  • EU Importers

Distributors are also Economic Operators and have certain obligations under the MDR/IVDR, nevertheless, they are not registered in EUDAMED.

You will then be issued a Single Registration Number. A Single Registration Number (SRN) is a unique number assigned to the Economic Operators by a European Competent Authority. The SRN is then published on EUDAMED’s public website. SRN intends to provide a better traceability and transparency of Economic Operators and their devices associated. The SRN provides a clearer vision of which medical device companies are on the EU market, which products are placed on the market by those companies, and highlight if they are respecting the requirements outlined in the Regulations (MDR and IVDR). The EUDAMED SRN is quite similar the FDA Establishment Registration Number.

3- Finally, after the Actor registration is completed, manufacturers can register their products in the EUDAMED, following the UDI/Devices Registration steps

The following information are needed to complete the EUDAMED medical device registration:

  • Basic UDI-DI
  • UDI details: UDI-DI, UDI-PI
  • Authorized Representative, when applicable
  • Device classification
  • Device Trade Name(s), Model(s), Reference/Catalogue numbers
  • Where the device is or will be placed on the marketed
  • CE Certificate details, when applicable
  • EMDN code
  • Device characteristics like: single use, sterile, latex presence, storage handling conditions and critical warnings or contra-indications, when applicable
  • Company responsible for design, if it is not the registered manufacturer
  • Company responsible for manufacturing, if it is not the registered manufacturer

EUDAMED: 6 modules will be available

These 6 modules cover the lifecycle of the medical device for regulatory compliance and surveillance:

1. Actors Registration

Actors registration means registration of manufacturers, authorized representatives, and importers. It provides each registered entity with a Single Registration Number (SRN). EUDAMED edited the following document to describe how it works: EUDAMED user guide - Economic Operators – Actor module.

Content of the document:

  • Provides instructions on how to log in and register as an actor
  • Provides instructions on how to enter the required data (identifying your authorized representative, entering the validity start and end dates of the written mandate with the Authorised Representative, uploading the summary mandate document, etc.).
  • Describes the user profiles per actor and their hierarchy.
  • Explains how to view the details for the actors, how to navigate between the different information related to them, and search for the Authorized Representatives.
  • Provides information for different scenarios like incomplete or incorrect information, wrong Competent Authority and/or Authorized Representative, duplicate actors, non-applicable requests, or suspected fraud.
  • Gives instructions on how to find the Authorized Representative from the search page, how to enter the Actor ID/SRN, how to specify the mandate’s validity start-date and end-date, and how to upload your summary mandate document.
  • Etc.

2. UDI/Device Registration:

The Unique Device Identification (UDI) and Device Registration module allows manufacturers to register their devices before placing them on the market. This includes details about the device and its classification. EUDAMED edited the following document to describe how it works: EUDAMED user guide UDI Devices – Production.

Content of the document:

  • Basic UDI-DI Identification Details: instructions on how to fill in the Basic UDI-DI identification details are provided. EUDAMED will validate the Basic UDI-DI code based on the specific format for each Issuing Entity and will prevent the actor from going further if the code is not valid. As a Basic UDI-DI must be unique, if the Basic UDI-DI code already exists in EUDAMED, the system will prevent from recording.
  • Special Device Types: it is currently not possible to register devices with certain special device types, including standard soft contact lenses, rigid gas permeable (RGP) contact lenses, made-to-order soft contact lenses, spectacle frames, spectacle lenses, and ready-made reading spectacles.
  • UDI-DI Code: instructions on how to enter the UDI-DI code are given. The code must be 14-digit, including the check digit that will be used by EUDAMED to validate the UDI-DI code. If the GS1 UDI-DI (GTIN code) has less than 14 digits, leading zeros must be added to reach 14 digits.
  • Managing Device Information (DI): instructions on how to manage device information are provided, including how to delete a draft Basic UDI-DI/EUDAMED DI, how to create a new version or to update a Basic UDI-DI/EUDAMED DI, and how to view historical versions for Basic UDI-DI/EUDAMED DI.
  • Discarding Registered UDI-DIs/EUDAMED IDs: instructions on how to that discard operation acts as final deactivation are provided. A device in “discarded” state is not listed and will not be viewed in the public site of EUDAMED. Nevertheless, it can be viewed by the owner of the discarded devices (Manufacturer), the Competent Authority, and the Notified Body actors.

3. Notified Bodies and Certificates:

This module provides information about Notified Bodies and the certificates they issue. EUDAMED edited the following document to describe how it works: EUDAMED user guide Notified Bodies & Certificates.

Content of the document:

  • Gives instructions on how to review different versions of a document.
  • Guides on how to register a refused certificate.
  • Describes how to register a withdrawn application.
  • When done, the user can click on ‘Submit’. If a translation in English is not provided, the system will display a warning message that an English translation is required. It also explains how to view the SS(C)P version history ( (Summary of safety and (clinical) performance).
  • Gives instructions on how to download certificates and refused certificates.

4. Clinical Investigations and Performance Studies:

The Clinical Investigations and Performance Studies module records details of clinical investigations for medical devices and performance studies for in-vitro diagnostic devices.

5. Vigilance:

The Vigilance module facilitates reporting and evaluation of serious incidents and field safety corrective actions associated with medical devices and in-vitro diagnostic devices.

6. Market Surveillance:

The Market Surveillance module benefits for competent authorities to coordinate activities and to share information related to the monitoring of medical devices and in-vitro diagnostic devices on the market.

MDCG ressources:

  • MDCG 2022-12 – Guidance on harmonised administrative practices and alternative technical solution until Eudamed is fully functional (for Regulation (EU) 2017/746 on in vitro diagnostic medical devices)
  • MDCG 2021-13 Rev. 1 – Questions and answers on obligations and related rules for the registration in EUDAMED of actors other than manufacturers, authorised representatives and importers subject the obligations of Article 31 MDR and Article 28 IVDR
  • MDCG 2021-1 Rev. 1 – Guidance on harmonised administrative practices and the technical solutions until EUDAMED is fully functional
  • MDCG 2020-15 – MDCG Position Paper use of EUDAMED actor registration module and the Single Registration Number (SRN) in Member States
  • MDCG 2019-5 – Registration of legacy devices in EUDAMED
  • MDCG 2019-4 – Timelines for registration of device data elements in EUDAMED

We are at your service

Since the arrival of Regulation 2017/745, new requirements are requested and form part of the documentation to be presented to the notified body (e.g. review of the in-depth clinical evaluation, PMS procedure, QC results from validation products, proof of staff skills, etc.).

CSDmed brings its expertise and a methodical approach to its clients, start-ups, manufacturers, importers and distributors of medical devices, thanks to a team of specialized experts and consultants, who will be able to address the MDR transition in its entirety

🔗 Contact us and find out how we can help you.