Theme Classification
Target Audience Manufacturers, Notified Bodies (NB)
Products concerned MD
Documents mentioned

MDR (EU) 2017/745

Annex VIII

This MDCG document is a real mine of information for interpreting the classification rules of the MD Regulation, which until then had many grey areas. It provides many specifications and clarifications on the key definitions of the Annex VIII necessary to apply the classification principles and rules. The 22 classification rules are presented in flowcharts and illustrated with several examples.