Important legal notices
 
Search on EUROPA   
Back to IDABC home page Back to IDABC home page
 
 

EUDAMED: European database for medical devices

Medical Devices
   
Medical devices are in constant evolution. The healthcare sector, citizens and society directly benefit from technological progress and innovation. On the other hand, the speed of change and the degree of sophistication also provoke new challenges.
The European Database for Medical Services - an information system for exchanging legal information related to the application of European Union Directives on medical devices between the European Commission's Directorate General for Enterprise and Industry and the Competent Authorities in the European Union Member States - will ensure that incompatible national regulations do not compromise the free circulation of medical devices in the Internal Market. In this manner, patients will continue to receive quality health care, as well as a high level of health protection.

 

  

Last update: July 2007


  

Objectives

The overall aim of the project is to develop a database, as called for in the directives on medical devices, which can subsequently be used for exchanging information relating to application of the European Directives on medical devices.
The exchange will be based on a database (EUDAMED-database) and a telecommunication network between the EC-services competent in the relative domain, and the CA (Competent Authority) in a Member State.
In the second phase, with the EUDAMED-database loaded with high quality operational data, a vigilance-extension and other enhancements will be developed. With this vigilance module, Member States will be informed on incidents and near-incidents relating to certain devices on the market, which will significantly improve co-ordination.
The provision of a database for the registration of devices and incidents will equip businesses and citizens with a single information system, available across all Member States. It will not only streamline the market access procedures for businesses, but also provide an information tool to authorities allowing them to take preventive actions in the interest of public health.

 

Technical Functionalities & Approach

Regulatory data in accordance with medical device directives shall be stored in a European databank accessible to the Competent Authorities. This will enable them to carry out tasks on a well-informed basis.
 
The databank shall contain the following:
  • Data related to registry of manufacturers and devices in accordance with Article 10
  • Data related to certificates issued, modified, supplemented, suspended, withdrawn or refused according to the procedure, as laid down in Annexes III to VII
  • Data obtained in accordance with the vigilance procedure, as defined in Article 11
  • Data exchange will be based on an agreed standard format (XML, …) and web-interfaces will be extensively used.
The EUDAMED system will be split into various interconnected subsystems. The focus will be placed on Medical Devices. The aim is to provide access to all relevant information concerning Medical Devices. In case of problematic use of a device, the vigilance module will collect vigilance information relative to this device, so that every Member State can verify the incident history of a device present on the market.
 
This system will:
  • establish connectivity between the competent authorities and the European database for medical devices hosted by the European Commission (Directorate General Enterprise & Industry)
  • be able to load, extract, modify data
  • compile reports and queries on the European Database for Medical Services
  • use already existing components
  • be modular, so that its components can be reused for similar purposes linked to directives covering other domains.
During the start-up phase, data-migration processes must be planned between the Member State Competent Authorities' infrastructure and the European Database for Medical Devices.
 
 
 

Potential Beneficiaries

  • Benefits for the sector:
    The database fulfils the obligation under the directives for the development of such a system. It is in line with the Directorate and Sectors’ objectives in promoting the open method of coordination between Member States and the financial support to encourage competitiveness, entrepreneurship and innovation.  
  • Benefits for the national Member States administrations:
    More efficient handling of the notification processes, e.g. the notification flow is automated (no more faxes & letters). With data related to devices and incidents in one database, better Market Surveillance can be achieved with resulting benefits to the protection of Public Health.  
  • Benefits for citizens:
    Increased protection of Public Health e.g. the centralisation of data on incidents related to medical devices on the European market allows for earlier or preventive action at a national or coordinated EU-wide level.
  • Benefits for enterprises:
    A more efficient way of handling the device registration process; e.g. in vitro, diagnostic medical devices can be registered in a single country and be applicable for all Member States as opposed to registering in each Member State, as is the current process.
Top of page
     

Key Data

Project start date
2004
Project completion date
2008
Project status
ongoing
IDA budget
IDABC budget
2004          €   39,169
2005-2007  € 200,000
Service in charge
 
Associated service
Directorate General for Enterprise and Industry - Consumer goods, Unit F3 - Cosmetics and Medical Devices
Directorate General for Enterprise & Industry - Unit R3 - Informatics
Responsible action manager
CATALANI Paolo
Contact
Countries involved
All EU member states
Public websites
 
 
 

Documentation:

Back to: