Risk-based thinking has been an important concept in ISO 9001 based quality management system. For medical devices, ISO 14971 provides a generic risk-management framework, from design and development through production and post-production activities, which can be applied in a QMS based on ISO 13485.
A new version of ISO 14971 has been published in 2019, which is to replace ISO 14971:2007. The revised standard ISO 14971:2019 consists of 10 clauses and 3 informative annexes. It provides a thorough process for manufacturers to identify hazards, assess risks, control risks, and monitor the effectiveness of risk controls in the medical device’ life time. The revised standard provides clearer guidance in the application of risk management in alignment with the safety and performance principles.
The new European Medical Device Regulation (MDR) and In Vitro Diagnostic Medical Device Regulation (IVDR) require manufacturers to implement a quality management system that incorporates risk management. ISO 14971:2019 is aligned with the general safety and performance requirements within the new EU MDR and EU IVDR.
A 3-year transition period is anticipated for organizations to address the changes from the new version of standard.
Click here to learn more about the primary changes to ISO 14971:2019.