The European Commission, in a recent decision, made the EUDAMED mandatory for member states starting May 1, 2011. EUDAMED is a European databank for medical devices that is required by the product directives. For example, the Medical Device Directive (MDD) Article 14a calls for the “Regulatory data in accordance with this Directive shall be stored in a European database accessible to the competent authorities to enable them to carry out their tasks relating to this Directive on a well informed basis.”
The European Union maintains information on EUDAMED at http://ec.europa.eu/enterprise/sectors/medical-devices/market-surveillance-vigilance/eudamed/index_en.htm
Depending on the applicable directive (MDD, IVDD, or AIMD), 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- data relating to certificates issued, modified, supplemented, suspended, withdrawn or refused,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.
One of the data requirements includes the use of the Global Medical Device Nomenclature (GMDN). The European standard (harmonized to the MDD and other product directives) EN ISO 15225 “Nomenclature – specification for a nomenclature system for medical devices for the purpose of regulatory data exchange” describes the nomenclature requirements. The current versions are: EN ISO 15225:2000, EN ISO 15225:2000/A1:2004, and EN ISO 15225:2000/A2:2005. GMDN is maintained by the GMDN Agency, http://www.gmdnagency.com
EUDAMED is an information exchange between national competent authorities and the Commission and is not publicly accessible.