Major ISO 14971:2019 Changes that all Users and Manufacturers should know

The latest version of ISO 14971:2019 has 8 major changes that all users and manufacturers should be aware of. Most of these following requirements have been called out in MDR:

1. The 1^st change focuses on the benefits expected from the use of the medical device and the use of benefit-risk analysis. By referring Technical, Regulatory, Economic, and Sociological context, the benefit-risk analyses can be evaluated, and risk management decisions can be taken.
2. Data and system security were included in ISO 14971 as an additional hazard that can be addressed by risk management process and a separate process is not required to manage risks.
3. The Risk Management Plans (RMPs) must include a method to evaluate the overall residual risk and criteria for acceptability. The contributions of all residual risks, in relation to the benefits of the intended use need to be measured and a policy should be in line to determine the acceptable risk.
4. When the overall residual risk is evaluated and accepted, then individual residual risks can be disclosed. An Instructions for Use (IFUs) and User Manuals should contain appropriate precautions, warnings and contraindications associated with these significant residual risks for the user to making decision on the use of a medical device.
5. A formal review needs to be performed and documented in the Risk Management Report (RMR) on the device concerns and actions can be created and closed before the commercial release.
6. The production and post-production activities requirements have been clarified with more details provided on collection and actions to be performed per the following steps:

• Information collection
• Information review
• Actions to be taken based on the review of information

1. Some important annexes have been moved to ISO/TR 24971 to explain the requirements in more details.
2. New definitions have been added i.e. Benefit, Reasonably foreseeable misuse and State of the art.