ISO announces revised regulation

Revisions have been made by the International Organisation for Standardization (ISO) to its ISO 14971 regulation.

The standard was updated to better align with changes in medical device changes around the world. The revision aims to clarify the technical requirements by including more detailed information on the steps manufacturers must take to meet those requirement. It also includes new and updated terminology to reflect the current market needs. The guidance has been moved to the standard’s accompanying technical report ISO/TR 24971, Medical devices – Guidance on the application of ISO 14971, which was revised in parallel.

The regulation covers the application of risk management to medical devices, specifies the terminology, principles and process for managing the risks associated with medical devices, including software as a medical device (SaMD) and in vitro diagnostic (IVD) medical products.

Peter Linders, chair of the ISO technical committee that developed the documents, explained how it is a manufacturer’s responsibility to reduce the risks of medical devices and commented: “ISO 14971 helps manufacturers to identify the hazards and estimate the risks associated with a medical device, enabling them to control those risks and monitor the effectiveness of the controls they put in place.”

ISO 14971 was developed jointly by technical committees ISO/TC 210, quality management and corresponding general aspects for medical devices, and IEC/TC 62, electrical equipment in medical practice, of the International Electrotechnical Commission (IEC), with involvement from regulators from around the world. It can be purchased from your national ISO member or through the ISO Store.