12. December 2019

In the MDCG 2019-13 the EU Commission publishes further details on the sampling of the technical documentation for review by the Notified Body during the conformity assessments of Medical devices and IVDs. The guidance explains how to identify product categories ( (for Class IIa and Class B) and generic product groups (for Class IIb and Class C) . Manufacturers will need to utilize two "coding" systems: The MDA/MDN codes (MDR) or IVR codes (IVDR) according to Regulation (EU) 2017/2185, which is...