Author: Nupur Srivastava, PhD | December 7, 2020
The International Organization for Standardization (ISO) 14971:2019 places more emphasis on the risk to benefit ratio of medical devices, asking manufacturers to show that their device is not only safe but also provides a medical benefit. The reference to benefit is included throughout the standard, and the definition for “benefit” is included for the first time.
ISO 14971:2019 Definition of Benefit: a 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.
As outlined in the standard, risk has two key components:
The newest ISO 14971:2019 standards emphasize that manufacturers need to demonstrate that the benefits outweigh the risks, as well as mitigating risks. Clause 7.4 of ISO 14971:2019 has even been retitled “Risk/Benefit Analysis” to align with regulatory changes.
Examples “benefits” provided ISO 14971:2019:
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