EUDAMED Status Update
Understanding The European Database on Medical Devices
Medical Device Manufacturers should follow the EUDAMED implementation plan, and make themselves familiar with the information stored in the database’s modules. This is crucial to gain compliance in the EU market. However, the development and deployment of EUDAMED has recently changed.
What is EUDAMED?
EUDAMED is the European Database on Medical Devices. It is the IT system developed by the European Commission to implement Regulation (EU) 2017/745 on medical devices and Regulation (EU) 2017/746 on in vitro diagnosis medical devices.
They structure the multipurpose and interoperable system database around 6 interconnected modules and a public website:
- Actor Registration – ACT.
- Unique Device Identification/Devices Registration – UDI.
- Notified Bodies and Certificates – CRF.
- Clinical Investigations and Performance Studies – CIPS.
- Vigilance and Post Market Surveillance – VGL.
- Market Surveillance – MSUEU.
What is stored in the EUDAMED?
Module ACT – Actor Registration
This module allows actors to register. Actors are manufacturers, system & procedure pack producers, importers and EU authorised representatives. An economic operator submits an actor registration request. Upon approval, the selected national competent authority issues the Actor ID/Single Registration Number (SRN) generated by EUDAMED. The SRN identifies the Actors, who will have access to EUDAMED upon registration and verification of the data provided.
It is important to note that all actor information registered in EUDAMED has been publicly available since 1st December 2020.
Module UDI – Unique Device Identification/Devices Registration
The UDI module contains all device-specific information and data divides into BASIC UDI-DI and the UDI-DI. The purpose of BASIC UDI-DI is to map all common properties of a product group, while the UDI-DI only contains the product-specific information.
Economic Operators have the responsibility for managing all UDI attributes in their own companies and transferring the data to EUDAMED.
Information on the registered Basic UDI-DI, UDI-DI and Device is publicly available.
Module CRF – Notified Bodies and Certificates
This module stores certificates issued by Notified Bodies on Quality Management System and Conformity Assessment in accordance with MDR 2017/745 and IVDR 2017/746. The purpose of this module is to facilitate communication between the Notified Bodies, as well as monitor the consultation procedures for clinical evaluations.
They will grant public access to the registration of certificates of conformity, their scope and validity period, as well as the reports of the Notified Bodies on the SSCP.
Module CIPS – Clinical Investigations and Performance Studies
This module manages clinical investigation and performance evaluation data, as well as applications for clinical performance studies. We can also submit follow-ups, post-market product changes, reports, and trials in this module.
Clinical Investigation Registration, Results Reporting and Publication are accessible to the public. Application Documents will potentially be accessible by the public.
Module VGL – Vigilance and Post-Market Surveillance
We can submit Periodic Safety Update Reports (PSUR), Periodic Summary Reports (PSR), Reporting of Serious Incidents and Field Safety Corrective Actions (FSCAs) and Field Safety Notices (FSNs) via the Vigilance Module. They automatically distribute FSCa to the appropriate authorities after we have reported them in the Vigilance Module.
While not available to the public like the previous modules, there will be partial public access for manufacturer incident reports and Field Safety Notices.
Module MSU – Market Surveillance
The purpose of this module is to facilitate cooperation and coordination between competent authorities of EU Member States. The summary of the results of the reviews and assessments of the market surveillance activities will be publicly available.
Guidance on GMDN and EDMN codes
The EMDN codes are European Medical Device Nomenclature codes and they will replace current listed GMDN. EMDN are a set of alphanumeric codes that are used to identify medical devices and their characteristics, such as the device type, intended use, and other attributes. In comparison to GMDN codes, EMDN terms are drafted more widely, so one EMDN term covers numerous types of medical device, and products falling within different GMDN terms may be covered by the same EMDN term.
The EMDN codes will be used in Eudamed, which is the European Databank on Medical Devices. Eudamed will serve as a centralized repository of medical devices classified against the EMDN device type categories. In this way information on medical devices and their device categories (SoTA) that are placed on the market in the EU, and will facilitate the exchange of information on safety and performance of medical devices.
We will use the EMDN codes in Eudamed to help classify medical devices and facilitate the exchange of information between different stakeholders. The codes will be used to identify the device type, intended use, and other characteristics of the medical device, which will help to ensure that the correct device is being used for its intended purpose and that relevant information is available to regulatory authorities and other stakeholders.
Various Categories include:
(See excel sheet column K, create a table category, and example devices)
- ACTIVE-IMPLANTABLE DEVICES
- CARDIOCIRCULATORY SYSTEM DEVICES
- DENTAL, OPHTHALMOLOGIC AND ENT DEVICES
- DEVICES FOR ADMINISTRATION, WITHDRAWAL AND COLLECTION
- DEVICES FOR GENERAL AND SPECIALIST DRESSINGS
- DEVICES FOR PERSONS WITH DISABILITIES NOT INCLUDED IN OTHER CATEGORIES
- DEVICES FOR UROGENITAL SYSTEM
- DIALYSIS DEVICES
- DISINFECTANTS, ANTISEPTICS, STERILISING AGENTS AND DETERGENTS FOR MEDICAL DEVICES
- Devices for the Nervous System and Spinal Cord”
- Various Devices (Includes scalpels, lancets, breastfeeding devices, ext.)
- ENDOTHERAPY AND ELECTROSURGICAL DEVICES
We can download a full set of EMDN terms from the European Commission website; https://webgate.ec.europa.eu/dyna2/emdn
What is the state of play of the implementation of EUDAMED?
As previously mentioned, the development and deployment of EUDAMED has been progressing over the years.
The module on Actor Registration (first module) went live in December 2020, and the UDI/Device Registration and Notified Bodies and Certificates modules (second and third modules respectively) have been available since October 2021.
There are three remaining modules – Clinical Investigations and Performance Studies, Vigilance and Post-Market Surveillance and Market Surveillance. They will launch these when EUDAMED becomes fully operational – as well as the mechanism for scrutiny and the CECP.
EUDAMED is not yet mandatory, but we can use the available modules voluntarily. We should note that once they declare the entire EUDAMED system (including all 6 modules) fully functional, its use will become mandatory for all manufacturers of Medical Devices. After an independent audit and once they have published a Commission Notice in the Official Journal, and in accordance with the transitional provisions set out in the Medical Device’s regulations, they will make this official.
You can find a more detailed timeline, forecasting the next steps for EUDAMED here.
Clinical Investigations in the UK
Updated MDCG Guidance on Clinical Investigation
