Advena understands that the Medical Device Coordination Group (MDCG) is currently revising the guidance document MDCG 2020-16 rev.4 – Guidance on Classification Rules for In Vitro Diagnostic Medical Devices under Regulation (EU) 2017/746. This update is part of ongoing efforts to enhance clarity and improve consistency across EU medical device guidance.
The current revision focuses specifically on Rule 7, which relates to the classification of certain in vitro diagnostic devices based on their intended use and risk profile. The clarification aims to ensure consistent interpretation and application of the rule across the EU, helping manufacturers and stakeholders better understand classification requirements and support regulatory compliance.
Advena will continue to monitor developments and provide updates as further details become available.
