The creation of the EUDAMED Database to comply with Art. 31 of the MDR (2017/745), Art. 28 of the IVDR (2017/746) and the MDGC 2020-15 Guidelines is being promoted by the European Union and applies to manufacturers, importers, authorised representatives and producers of systems or kits for procedures.

EUDAMED seeks to improve the general transparency and coordination between the member states of the EU and will consist of 6 modules. 

At Azierta we can offer you comprehensive advice during the process, starting with the management of the first of them, the actors module, which, although voluntary since last December 2020, will probably be mandatory within a year, as the development of the database progresses.