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.