Technical documentation sampling details published

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:


  1. The MDA/MDN codes (MDR) or IVR codes (IVDR) according to Regulation (EU) 2017/2185, which is originally only intended to identify the N.B. competency codes - see our news "Final version of the first implementing Act under the MDR"
    The relevant codes will act as the product category used for sampling class IIA MD or Class B IVD products‘ TD.
    The MDCG 2019-14  "Explanatory note on MDR codes" gives further explanations on how to use the MDA/MDN codes
  2. The so called European Nomenclature on Medical Devices (EMDN) which is based on the Italian CND Code t - see our News: "The European Nomenclature will be the Italian CND"
    The 4th level of the EMDN which means the combination of one letter plus 6 digits of the codes will identify the generic product group as used for sampling class II B products (except those being implanted or being active for the delivery or removal of pharmaceutical substances)