MDCG 2021-24 : Guidance on classification of medical devices – October 2021

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.