Terminology update, most noticeably the definitions:
Benefit: Positive impact or desirable outcome of the use of a medical device on the health of an individual, or a positive impact on patient management or public health.
State of the art: Developed stage of technical capability at a given time as regards products, processes and services, based on the relevant consolidated findings of science, technology and experience.
Reasonably foreseeable Misuse: Intentional or unintentional use of a product or system in a way not intended by the manufacturer, but which can result from readily predictable human behaviour.
Risk/benefit analysis is now called “Benefit-risk analysis”
Furthermore, minor changes have been made to other terms such as: accompanying documentation, harm, in vitro diagnostic medical device, manufacturer and use error.
The section “Production and post-production information” has been split into four sub-sections:
- General
- Information collection
- Information review
- Actions
Several annexes have been moved from ISO 14971 to ISO 24971, which is a guidance document on how to apply risk management according to ISO 14971.
Recommended actions
- Revise your risk management procedures and templates to reflect the updated terminology of ISO 14971:2019.
- Ensure that your risk management plan includes a method to evaluate overall residual risk and the criteria for acceptability, taking into account contributions of all residual risks in relation to the benefits of the intended use of the medical device.
- This method can include gathering and reviewing data and literature for the device being considered and for similar devices already on the market.
ISO 24971 suggests that some risk management activities can be performed by external consultants or specialists. See Implementing an effective risk management process to learn how MGS Design & Development’s specialists can help your project.
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