National Working Group (NAKI)
The “National Working Group for the Implementation of the MDR and IVDR” was launched in 2017 by the Federal Ministry of Health. The aim of the NAKI is to develop proposals for the meaningful, practical application and implementation of the requirements of the MDR and IDVR. These proposals, which are defined in collaboration with German economic operators and authorities, are then presented to the EU Commission. Members of the NAKI are the German Federal Ministry, higher federal authorities, manufacturers’ associations, medical device interest groups, pharmaceutical wholesalers, the German Hospital Federation, the National Association of Statutory Health Insurance Funds (GKV Spitzenverband), and the Action Alliance for Patient Safety (Aktionsbündnis für Patientensicherheit).