MDCG 2020-16 Rev. 3 – Guidance on Classification Rules for in vitro Diagnostic Medical Devices under Regulation (EU) 2017/746 – Juillet 2024

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.