MDCG 2020-16 Rev. 2 : Guidance on Classification Rules for in vitro Diagnostic Medical Devices under Regulation (EU) 2017/746 – November 2020.

This MDCG document is a real mine of information for interpreting the classification rules of the IVD Regulation, which until then had many grey areas. It provides new definitions, precisions/clarifications but also many examples illustrating each classification rule.