During the summer the MDCG released two important documents: “Guidance on standardisation for medical devices” & “Guidance on Classification Rules for in vitro Diagnostic Medical Devices under Regulation (EU) 2017/746”
The MDCG issued significant revisions to two critical guidance documents. These revisions are aimed at ensuring that manufacturers can navigate the complex landscape of European harmonised standards more effectively. For instance, the Guidance on Classification Rules for In Vitro Diagnostic Medical Devices offers further clarity on risk-based classification, with special emphasis on companion diagnostics and software, to ensure that IVD manufacturers can accurately classify their devices in compliance with Regulation (EU) 2017/746, ultimately supporting safer and more efficient product development.
For more information, please consult the documents directly:
