Published the new ISO 14971: 2019 - Application of risk management to medical devices
In December 2019, the third edition of the ISO 14971 standard - Application of risk management to medical devices has been published.
Among the various novelties introduced, the main changes are the following:
- More attention is given to the benefits that are expected from the use of the medical device. The term benefit-risk analysis has been aligned with terminology used in some regulations.
- The method for the evaluation of the overall residual risk and the criteria for its acceptability are required to be defined in the risk management plan. The method can include gathering and reviewing data and literature for the medical device and for similar medical devices and similar other products on the market. The criteria for the acceptability of the overall residual risk can be different from the criteria for acceptability of individual risks.
- The requirements for production and post-production activities have been clarified and restructured
- The review before commercial distribution of the medical device concerns the execution of the risk management plan. The results of the review are documented as the risk management report.
- Several informative annexes are moved to the guidance in ISO/TR 24971, which has been revised in parallel.
Merc can support you in the implementation of the new requirements of ISO 14971:2019 in your Quality Management System. In case of need please contact us at firstname.lastname@example.org or click here: https://www.merc21.it/quality-system-detail.asp/l_en/id_44/implementation-of-new-iso-14971-2019-application-of-risk-management-to-medical-devices.html