Generic device group (sampling)

The number of generic device groups in a manufacturer's portfolio drives how many technical documentation files a notified body reviews over the certificate period.

Generic device group: is to be understood: • in respect of the MDR as the 4th level of the European Nomenclature on Medical Devices (EMDN) (i.e. combination of one letter plus 6 digits), and • in respect of the IVDR as the 3rd level of the EMDN (i.e. combination of one letter plus 4 digits respectively) in combination with the most appropriate IVP code.

MDCG 2019-13 Rev.1, Section 3, Definitions (3.2)