EUDAMED OVERVIEW
What is EUDAMED?
EUDAMED is the European Database on Medical Devices 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.
The European Database on Medical Devices is a collection of databases and electronic systems established to collate & disseminate information regarding devices on the EU market, relevant economic operators, conformity assessments, notified bodies, certificates, clinical investigations, vigilance and market surveillance.
EUDAMED will improve transparency and coordination of information regarding medical devices available in the EU market.
EUDAMED Database Modules
- 1. Actors Registration
- 2. Device Registration (UDID)
- 3. Notified Bodies and Certificates
- 4. Clinical Investigations and Performance Studies
- 5. Vigilance and Post-Market Surveillance
- 6. Market surveillance
- A. MDR EUDAMED Public Site
Actors
Registration
This module allows manufacturers (actors) to register and later be clearly identified with the help of the SRN (Single Registration Number) every economic actor can be clearly identified. After registration and verification of the data provided, the actors will have access to EUDAMED
UDI
Device
The UDI module will contain all device-specific information and have the same functions as the comparable database of the American Health Authority (FDA) GUDID.
CRF
Certificate
Any medical device distributed in Europe will require a valid approval certificate in the future in accordance with MDR 2017/745 and IVDR 2017/746. This certificate certifies that the product meets all the regulatory requirements of a medical device.
Investigation
Clinical Investigation Performance studies
According to the new Medical Devices Regulation (MDR), manufacturers of medical devices are required to conduct a clinical assessment for all their products, regardless of the risk class, including post-market clinical follow-up (PMCF). The clinical evaluation is an essential manufacturing task and an integral part of a manufacturer’s quality management system (Article 10, paragraphs 3 and 9f MDR). The clinical review will verify the manufacturer’s safety and performance, including clinical benefit.
Vigilance
Vigilance & Post-Market Surveillance
Any serious incident involving medical devices must be documented and provided. In the technical documentation, the number of incidents and objects must be reported.
Surveillance
Market Surveillance
In the module MSU the results of the market surveillance are reported back. The competent authorities are those who carry out market surveillance and publish the reports.Public can view a summary of the results of the reviews and assessments of the market surveillance activities of a Market Surveillance.
MDR EUDAMED
Public Site
According to the new Medical Devices Regulation (MDR), manufacturers of medical devices are required to conduct a clinical assessment for all their products, regardless of the risk class, including post-market clinical follow-up (PMCF). The clinical evaluation is an essential manufacturing task and an integral part of a manufacturer’s quality management system (Article 10, paragraphs 3 and 9f MDR). The clinical review will verify the manufacturer’s safety and performance, including clinical benefit.
- 1. Actors Registration
- 2. Device Registration (UDID)
- 3. Notified Bodies and Certificates
- 4. Vigilance and Post-Market Surveillance
- 5. Clinical Investigations and Performance Studies
- 6. Market surveillance
Purpose of EUDAMED
- Enhance overall transparency through better access to information for the public and healthcare professionals about devices placed in the EU market.
- Allow the unique identification of devices within the EU market to facilitate post-market surveillance & traceability.
- Enable Competent Authorities of Member States and the European Commission to carry out their tasks pertaining to the Medical Device Regulation (MDR) and enhance cooperation between them.
- Provide fast access and flow of information related to device information, certificates, vigilance & clinical investigations.
- Enable manufacturers & authorized representatives to comply with the information obligations for the registration of medical devices.
Did You Know?
For IVD manufacturers (In Vitro Diagnostic devices), the date of application for IVDR is 18 months after the EUDAMED system becomes fully functional.
Did You Know?
EU MDR (Europe’s Medical Device Regulation) came into effect on 26 May 2021, twelve months after the original planned Date of Application due to Covid-19 pandemic.
Did You Know?
26 May 2021 marks the start of transition arrangements from the former Medical Device Directive (MDD) to new Medical Device Regulation (MDR) until 26 May 2024.
Did You Know?
The Actor Registration module of EUDAMED is already available for production use. The next two modules, for Device Registration (UDI) and Notified Bodies & Certificates, are planned to go-live in September 2021.
Did You Know?
A “fully functional” EUDAMED system is expected to go-live in Q4 of 2022. It is still unclear as to whether this timeline includes the 6 months for system audit before EUDAMED go-live is recorded into the EU Parliament’s journals which marks the official start of mandatory device registration using EUDAMED.
Did You Know?
From 26 May 2024, all certificates issued under the former MDD/AIMDD will become void, if they have not already expired. Certificates that expire between now and May 2024 for products already in the market will need to be recertified under MDR. Any new products placed into the EU markets after 26 May 2024 will need certificates that meet MDR requirements.