Understanding EUDAMED – A Key Resource for Medical Device Registration in the EU
In the vast landscape of medical devices, one may wonder how regulators manage the enormous amount of information related to manufacturers, product details, safety reports, and clinical trials. The answer, for those operating in the European Union (EU), is a robust, secure web-based portal known as EUDAMED, the European Database on Medical Devices. So, what is EUDAMED, and how does it impact medical device companies, regulators, and consumers? Let’s delve deeper.
EUDAMED, an abbreviation of European Database on Medical Devices, is initiatives developed by European Commission. It primary purpose to enhance market transparency and oversight in medical device field by providing comprehensive repository of information on medical devices and their respective manufacturers active within the EU.
EUDAMED is more than just repository; it multi-faceted tool that integrates various processes related to medical devices 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, its important to understand that EUDAMED is cornerstone of 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 authorised representative—must first apply 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, at manufacturers enter relevant devices data into the system.
Manufacturers are required to provide detailed information about their devices, including the product’s unique devices identification (UDI), details of clinical investigation 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.
To summarize, EUDAMED is a key component of the European medical device regulatory framework, acting as central hub of information for all stakeholders. Understanding what is EUDAMED, how it operates, and the steps involved in EUDAMED registration is crucial for medical device manufacturers who wish to operate within the EU. For consumers and health professionals, EUDAMED provides transparency, instilling confidence in the medical devices they use and trust.
By offering comprehensive, accessible, and transparent view of medical devices market, EUDAMED marks significant step forward in ensuring the safety and efficacy of medical devices in EU, ultimately protecting the health of millions of individuals.
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 actor, and search for Authorised Representatives.
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 v 2.11. 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 discard operation acts as final deactivation. A device in state discarded is not listed and cannot be viewed in public site of EUDAMED. However, it viewed by Manufacturer (owner of the discarded devices), 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.
Other helpful documents and sources:
MDCG 2022-12Â – 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
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