Category of devices

MDCG 2019-13 uses the codes to decide which technical documentation a notified body samples for class IIa, IIb, B and C devices. The codes on the certificate and in the application therefore affect how many files are reviewed.

Category of devices: category of devices should be understood as the relevant MDA/MDN codes (MDR) or IVR codes (IVDR) according to Regulation (EU) 2017/2185 on the codes for the designation of notified bodies.

MDCG 2019-13 Rev.1, Section 3, Definitions (3.1)