CEN ISO/TR 24971:2020

ISO/TR 24971 guides to assist in developing, implementing and maintaining a risk management process for medical devices. It guides the application of ISO 14971 for various medical devices. These medical devices include active, non-active, implantable, and non-implantable medical devices, software as medical devices and in vitro diagnostic medical devices. ISO/TR 24971 describes approaches manufacturers can use for a risk management process conforming to ISO 14971.

When judging the applicability of the guidance, you should consider the nature of the medical devices to which it will apply. Consider how and by whom these medical devices are used, and the applicable regulatory requirements. The same structure and numbering of clauses and subclauses as in ISO 14971 is employed to facilitate the use of ISO/TR 24971.

The text ISO/TR 24971:2020 has been approved in Europe as CEN ISO/TR 24971:2020 without any changes.