- Regulatory framework
- Specific areas of development
- Market surveillance and vigilance
- Scientific and technical assessment
- Other related policies
- Dialogue between interested parties
- International Cooperation
European Databank on Medical Devices - EUDAMED
The Medical Device Directives contain provisions on a European databank for medical devices, which has been developed under the name Eudamed. The aim of Eudamed is to strengthen market surveillance and transparency in the field of medical devices by providing Member State competent authorities with fast access to information on manufacturers and authorized representatives, on devices and certificates and on vigilance and clinical investigation data, as well as to contribute to a uniform application of the Directives, in particular in relation to registration requirements.
Which information is stored in Eudamed?
Depending on the applicable directive, Eudamed contains data on:
- registration of manufacturers, authorized representatives and devices,
- data relating to certificates issued, modified, supplemented, suspended, withdrawn or refused,
- data obtained in accordance with the vigilance procedure and
- data on clinical investigations.
Who can access Eudamed?
Eudamed is a secure web-based portal acting as a central repository for information exchange between national competent authorities and the Commission and is not publicly accessible. Eudamed use is obligatory since May 2011.
Impact of Eudamed on IVD notifications
With the implementation of Eudamed, the transitional provision in Article 10 of Directive 98/79/EC, which obliges IVD manufacturers to give notification to every Member State concerned by the placing on the market of devices, cease to apply.
GMDN use in Eudamed
An important tool for Eudamed is the Global Medical Device Nomenclature (GMDN). The development of GMDN started with a mandate to CEN for the development of a structure for a medical device nomenclature. The result, the European standard EN ISO 15225 "Nomenclature - specification for a nomenclature system for medical devices for the purpose of regulatory data exchange", was further developed into a CEN technical report. Maintenance of this work was taken over by the GMDN Maintenance Agency which developed the Nomenclature (referred to as GMDN) into what it is today, a comprehensive, regularly updated web-based nomenclature accessible to manufacturers against license fees. GMDN presents the best practice for Eudamed purposes, even though, for the time being, data entry is also possible without providing a GMDN code.