ISO 14971:2019
The highlights of the updated risk management standard
- 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.
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.
- Revise your risk management procedure(s) and templates to reflect the updated terminology of ISO 14971:2019.
- Ensure that your risk management plan includes a method to evaluate the overall residual risk and the criteria for acceptability of overall residual risk; taking into account the 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 medical device being considered and similar medical devices on the market.
ISO 24971 suggests that some risk management activities can be performed by external consultants or specialists. Take a look at “Implementing an effective risk management process” to learn more about how Technolution’s risk management specialists can help you and your project.
Want to know more?
Insights you might also be interested in:
9 product families submitted for approval in timely MDR transition project
Transitioning from MDD to MDR compliance touches on several different business processes – all happening within a strict deadline. Therefore Ambu A/S decided to initiate the process well in advance and team up with Technolution..
Medical device regulations: obstacle or golden opportunity?
Healthtech magazine article shines the spotlight on the challenges and rewards of building your business processes around regulatory compliance.
Design Control as a discipline
Technolution’s design control specialists can quickly gain an overview of the product and the project to ensure a red thread during the design control documentation process.
