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EUDAMED: European Database on Medical Devices

EUDAMED
    Medical devices are in constant evolution. In the healthcare sector, citizens and society in general can benefit directly from technological progress and innovation. At the same time, the speed of change and the degree of sophistication obtained also create new challenges. EUDAMED will help to ensure that patients continue to receive good quality health care, and a high level of health protection, making sure that incompatible national rules or regulations do not compromise the free circulation of medical devices in the Internal Market.

Last update: 03/2005

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What is EUDAMED?
Objectives
How will it work?

Achievements
Who will benefit?
The role of IDABC
Technical information

Documentation

What is EUDAMED?

EUDAMED will be an information system for exchanging legal information related to the application of European Union Directives on medical devices between the European Commission's Enterprise and Industry Directorate General and the Competent Authorities in the European Union Member States. Its legal basis is laid down in Directives 90/385/EEC, 93/42/EEC, 98/79/EC and 2000/70/EC.

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Objectives

EUDAMED aims to help European authorities conduct market surveillance on medical devices through information exchange. The market surveillance on medical devices is a key component of the legal framework established by the Medical Devices Directives 90/385/EEC, 93/42/EEC and 98/79/EC. Under these Directives, Member States need to ensure that medical devices that are placed on the market and put into service comply with all provisions of the Directives, including the ‘essential requirements’, and that no obstacles are encountered for the free movement of approved devices. The Directives also require that data be stored to a database in a standardised format. The EUDAMED project aims to address the effective implementation of this provision of the Directives.

EUDAMED will also develop a vigilance module. This vigilance module will inform Member States on incidents or near-incidents in relation to certain devices on the market.

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How will it work?

EUDAMED will be a secure web-based portal acting as a central repository for information exchange between national competent Authorities and the Commission. It will comprise a database with high quality operational data loaded in accordance with the specifications set out in the medical devices Directives and an information exchange system that will act as the driver between the relevant bodies in the European Commission Services and Member States. The EUDAMED system will be split into different, interconnected subsystems. The focus will be placed on ensuring the effective collection and visualisation of all relevant information concerning medical devices. In case of problems with a device, the vigilance module will collect vigilance information relative to that device. This will give an overview to every Member State of the incident history of a device present on the market.

Data contained within the database will include:

  • Data related to registry of manufacturers, authorised representatives and devices;
  • Data related to certificates issued, modified, supplemented, suspended, withdrawn or refused according to established procedures;
  • Data obtained in accordance with the vigilance procedure on incidents or near-incidents which occur during the use of the medical device.

The vigilance module will report to EU Member States on incidents and near-incidents using electronic mail.

Users of the EUDAMED system will be able to load, extract and modify data, and to make reports and queries on the EUDAMED database. The system will use already existing components, and will be modular so that its components can be reused for similar purposes linked to Directives covering other domains.

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Achievements

  • Between 1997-1999 the Institut für Medizinische Dokumentation und Information (DIMDI) has carried out a feasibility study and an overall assessment of EUDAMED. During the feasibility phase the contractor has developed, installed and made accessible a database system for the exchange of regulatory data on medical devices.
  • A web-based interface has now been developed to enable direct input from Competent Authorities. Rules for data exchange have also been defined for Competent Authorities which wish to upload data from their own national system into EUDAMED directly.
  • Currently, only public data is planned to be processed. However, it is envisaged that in a later phase, data on initial reports will be stored in the EUDAMED system for vigilance purposes.
  • The next stage will therefore see the Member States network being adapted and sufficiently secured to be able to treat 'vigilance cases' related to defective devices.

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Who will benefit?

Citizens: By publishing and immediately distributing vigilance reports to all Member States EUDAMED will increase the safety of patients across Europe.

Public Administrations: A common European database will be a great asset for National Competent Authorities, especially when trying to remain vigilant or in conducting Europe-wide investigations or issuing warnings.

Businesses: (Medical Device Manufacturers) Launching new products on the market will become easier avoiding the negative impact of regulation on new innovations.

Professionals: A central database will guarantee the control and transparency of the European medical device market.

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The role of IDABC

The application to be hosted in the European Commission's Data Centre is financed by the IDABC Programme.

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Technical information

Project start date

2001

Project completion date

2006

Project status

Phase I - Operational
Phase II - Feasibility study

IDA budget

2001 271,000
2002
200,000
2003
244,000
2004 € 220,000
2005 € 110,000
2006 € 110,000

Responsible service

DG Entreprise

Project coordinator

Antonio Lacerda (Programme manager)
John Brennan (Project Coordinator)
Paolo Catalani
Patrick De Smedt

Contact

idabc@ec.europa.eu

Countries involved

All EU Member States

Public website

http://ec.europa.eu/enterprise/medical_devices/index.htm

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Documentation:


Global implementation plan
 EUDAMED GIP - September 2001 (PDF)
EnglishPDF[137 Kb]

 

 

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