Revision standard and guidance Risk Management Medical Devices

Periodically, standards are revisited by international and national committees to determine if they are still current or need revision or withdrawal. Through the voting process and based on comments received during the voting period in early 2016 on both ISO 14971:2007 (the standard for application of risk management to medical devices) and ISO TR 24971:2013 (the guidance on the application of ISO 14971), ISO determined that these documents needed to be updated and the policy for risk acceptability should be revised for clarity.

The resulting revision of ISO TR 24971:2013 — ISO TR 24971:2020 — provides extensive guidance in the informative annexes, discussions of the requirements in ISO 14971:2019, and further discussion of the terms “benefit” and “benefit-risk analysis”. It does not add any new requirements. It is only guidance or help for those implementing the standard.

For further information you can read this article of Med Device Online.