Sep 12

ISO 18969 Published

A new international standard, under development by ISO Technical Committee 194, titled ISO 18969 — Clinical Evaluation of Medical Devices, will define terminology, principles, and a process for conducting clinical evaluations of medical devices across their life cycle.

ISO 18969 — Clinical Evaluation of Medical Devices

It aims to help manufacturers and regulatory bodies to:
• assess clinical risks and benefits based on real-world data and clinical investigations;
• verify that devices meet safety, performance, and clinical benefit claims when used as intended;
• ensure a robust benefit-risk balance throughout the product’s life cycle, including post-market surveillance;
The document is currently at the Committee Draft stage; publication is expected around late 2025