ISO 14971: 2019 Risk Management in Medical Devices...
Information & Training. | Medical DevicesThe ISO 14971 standard has been developed for those involved in the manufacture of medical devices, however it can be used as guidance in developing and maintaining a risk management process for other products that are not necessarily medical devices.
The standard deals with processes for managing risks associated with medical devices. Risks can be related to injury, not only to the patient, but also to the user and other persons. Risks can also be related to damage to property (for example objects, data, other equipment) or the environment.
The 2019 edition cancels and replaces the second edition (ISO 14971:2007), which has been technically revised. The main changes compared to the previous edition are as follows:
– There are newly introduced definitions related to “benefit”, “reasonably foreseeable misuse” and “state of the art”:
The 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. Benefits can include positive impact on clinical outcome, the patient’s quality of life, outcomes related to diagnosis, positive impact from diagnostic devices on clinical outcomes, or positive impact on public health.
“reasonably foreseeable misuse”
Use of a product or system in a way not intended by the manufacturer , but which can result from readily predictable human behavior. Readily predictable human behavior includes the behavior of all types of users, e.g. lay and professional users. Reasonably foreseeable misuse can be intentional or unintentional.
“state of the art”
The 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. The state of the art embodies what is currently and generally accepted as good practice in technology and medicine. The state of the art does not necessarily imply the most technologically advanced solution. The state of the art described here is sometimes referred to as the “generally acknowledged state of the art”.
– 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 other widely utilized regulations.
– It is explained that the process described in ISO 14971 can be used for managing risks associated with medical devices, including those related to data and systems security.
– 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 to disclose residual risks have been moved and merged into one requirement, after the overall residual risk has been evaluated and judged acceptable.
– 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.
– The requirements for production and post-production activities have been clarified and restructured. More detail is given on the information to be collected and the actions to be taken when the collected information has been reviewed and determined to be relevant to safety.
- Validation. Classification. Regulation. Requirements. Current best practices.
- FDA cGMP’s, EU MDR’s / MDD’s.
- Risk Identification. Documentation. DHR’s. DMR’s.
- Information & Training presentation >>>
- Risk Identification. Risk Evaluation. Risk Mitigation. Risk Control. Etc..
- Requirements. Standards. Current best practices.
- Information & Training presentation >>>
ISO 14971:2019. Medical devices — Application of risk management to medical devices.