EUDAMED – All you need to know

30 Nov EUDAMED – All you need to know

Understanding EUDAMED

EUDAMED, an abbreviation of the European Database on Medical Devices, is an initiative developed by the European Commission. Its primary purpose is to enhance market transparency and oversight in the medical device field by providing a comprehensive repository of information on medical devices and their respective manufacturers active within the EU.

EUDAMED is more than just a repository, it’s a multi-faceted tool that integrates various processes related to the medical device lifecycle. It encompasses aspects such as product registration, post-market surveillance, vigilance, clinical investigations, and certification activities. Therefore, if you’re a manufacturer, understanding EUDAMED registration is not just essential—it’s a legal requirement.

How does EUDAMED registration work?

To start, it’s important to understand that EUDAMED is a cornerstone of the EU’s regulatory framework for medical devices, including the Medical Devices Regulation (MDR) and In Vitro Diagnostic Medical Devices Regulation (IVDR). These regulations mandate the registration of all medical devices and their manufacturers in the EUDAMED database.

The EUDAMED registration process involves several steps. A manufacturer or their authorized representative must first apply for a Single Registration Number (SRN). This SRN is a unique identifier used across the EU to identify the manufacturer in the EUDAMED system. Once the SRN is assigned, manufacturers can then enter relevant device data into the system.

Manufacturers are required to provide detailed information about their devices, including the product’s unique device identification (UDI), details of clinical investigations, any conformity assessment procedures, certificates issued, incidents and corrective actions, and details of any recalls or withdrawals. Once entered into EUDAMED, this data is accessible to competent authorities, notified bodies, economic operators, sponsors, and the public, as appropriate.

The six EUDAMED modules

These modules cover different aspects of the medical device lifecycle, facilitating both regulatory compliance and surveillance. The six modules are as follows:

1. Actors Registration:

This module is used for the registration of manufacturers, authorized representatives, and importers. It provides each registered entity with a Single Registration Number (SRN). The following document describes in more detail how it works.

EUDAMED user guide Economic Operators – Actor module. Link to document

Here are some of the main topics:

• It provides instructions on how to log in and register as an actor
• The guide provides instructions on how to enter the required data, such as identifying your authorized representative, entering the validity start and end dates of the written mandate with the Authorised Representative, and uploading the summary mandate document.
• It also explains the user profiles per actor and their hierarchy.
• The guide provides information on how to handle different scenarios such as incomplete or incorrect information, wrong Competent Authority and/or Authorised Representative, duplicate actors, non-applicable requests, and suspected fraud. It also explains how to complete an assessment and search and view registered actors.
• It provides instructions on how to find your Authorised Representative from the search page, enter the Actor ID/SRN, specify the mandate’s validity start-date and end-date, and upload your summary mandate document.
• The guide explains how to view the details for any actor, navigate between the different information related to the actor, and search for an Authorised Representative.

Additional sources:

Notified Bodies Access User Guide – Link to document

Competent Authorities Actor Validation Guide – Link to document

Designated Authorities User Guide – Link to document

2. UDI/Device Registration:

The Unique Device Identification (UDI) and Device Registration module enables manufacturers to register their devices before placing them on the market. This includes details about the device and its classification. The following document describes in more detail how it works.

EUDAMED user guide UDI Devices – Production Link to document

Here are some of the main topics:

Basic UDI-DI Identification Details:

The guide provides instructions on how to fill in the Basic UDI-DI identification details. EUDAMED will validate the Basic UDI-DI code based on the specific format for each Issuing Entity and will prevent you from going further if the code is not valid. If the Basic UDI-DI code already exists in EUDAMED, the system will prevent you from saving, as a Basic UDI-DI must be unique.

Special Device Types:

The guide notes that 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:

The guide provides instructions on how to enter the UDI-DI code, which must be a 14-digit code including the check digit that will be used by EUDAMED to validate the UDI-DI code. If the GS1 UDI-DI (GTIN code) is less than 14 digits, leading zeros should be added until it reaches 14 digits.

Managing Device Information:

The guide provides detailed instructions on how to manage device information, including how to delete a draft Basic UDI-DI/EUDAMED DI, how to update (create a new version) for Basic UDI-DI/EUDAMED DI, and how to view historical versions for Basic UDI-DI/EUDAMED DI.

Discarding Registered UDI-DIs/EUDAMED IDs:

The guide explains that the discard operation acts as a final deactivation. A device in state discarded is therefore not listed and cannot be viewed in the public site of EUDAMED. However, it can be viewed by the Manufacturer (owner of the discarded device), Competent Authority, and Notified Body actors.

3. Notified Bodies and Certificates:

This module contains information about Notified Bodies (organizations designated by EU member states to assess the conformity of certain products before being placed on the market) and the certificates they issue. The following document describes in more detail how it works.

EUDAMED user guide Notified Bodies & Certificates. Link to document

Here are some of the main topics:

• The guide provides instructions on how to review different versions of a document. You can click on the version you wish to review, which opens a summary of it.
• It also guides you on how to register a refused certificate. You can preview your choice or click submit.
• The guide explains how to register a withdrawn application. It mentions that you can click ‘Preview’ to double-check the content in each step.
• When you are done with certain tasks, you can click ‘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.
• The guide provides instructions on how to download certificates and refused certificates in a structured format.

4. Clinical Investigations and Performance Studies:

This module captures details of clinical investigations involving medical devices and performance studies involving in-vitro diagnostic (IVD) devices.

5. Vigilance:

The Vigilance module is designed to facilitate reporting and evaluation of serious incidents and field safety corrective actions associated with medical devices.

6. Market Surveillance:

This module helps competent authorities coordinate activities and share information related to the monitoring of medical devices on the market.

EUDAMED Roadmap – By when EUDAMED is fully functional (New Draft)

The EU Commission has published a new Draft Roadmap with updated timelines.

These are the following changes:

• Mandatory use of the modules Actor, Certificates, MSU, Vigilances, CI/PS by Q4 2027 as per EU MDR article 123(3)(d) and EU IVDR article 113(3)(f).
• Use of EUDAMED for Devices and Certificates registration becomes mandatory by Q2 2029 as per EU MDR article 123(3)(e) and EU IVDR article 113(3)(a).

Conclusion: It is still a long way to go and it can be expected that EUDAMED will be fully functional somewhere around 2029.

Data Exchange with EUDAMED

EUDAMED offers three main methods to exchange data with EUDAMED. This are the methods:

1. The User Interface (UI): This method involves manual data input through the EUDAMED application. It is the simplest form of data handling.
2. The XML Bulk Upload/Download: This semi-automated option allows data to be uploaded in XML format. Users need to generate XML files, which must be validated against the provided EUDAMED DTX service and entity model XSDs. While the generation of these files can be automated, the uploading and downloading actions remain manual. This method is useful for bulk uploading of existing information and requires some implementation effort by an IT team.
3. The Machine-to-Machine Data Exchange (M2M-DTX): This method enables automatic data exchange between an external backend system and EUDAMED’s backend services. It requires the external system to convert data into the XML format requested by EUDAMED DTX and to implement a specific data exchange protocol. This is the most complex and costly solution, suitable when there is a significant amount of data to be exchanged frequently, and when the cost of manual input outweighs the cost of automation.

The following documents describe in more detail how economic operators can exchange their data on EUDAMED.

Guidelines on Data Exchange with EUDAMED – Link to document

Machine-to-Machine Data Exchange – Link to document

Other helpful documents and sources:

EUDAMED public database – Link

EUDAMED information center – Link

MDCG 2022-12 – Guidance on harmonized administrative practices and alternative technical solutions 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, authorized representatives and importers subject to the obligations of Article 31 MDR and Article 28 IVDR

MDCG 2021-1 Rev. 1 – Guidance on harmonized administrative practices and alternative technical solutions until EUDAMED is fully functional

MDCG 2020-15 – MDCG Position Paper on the use of the EUDAMED actor registration module and of the Single Registration Number (SRN) in the Member States

MDCG 2019-5 – Registration of legacy devices in EUDAMED

MDCG 2019-4 – Timelines for registration of device data elements in EUDAMED

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