This makes the standard more user-friendly because it is easier to have a high-level view of the requirements. In an effort to simplify the primary document and make the requirements for compliance more clear, guided explanations and expanded dependencies were removed and included as annexes in the technical report (ISO TR 24971:2020). Although the risk management process is largely the same, there are three significant differences in the versions that manufacturers need to be aware of. Version 14971:2019, which was released in 2019, replaces the prior 2007 version. Key Changes with the Release of ISO 14971:2019 Make the standard up-to-date with 21st century medical device technology and the application of software used in medical devices.Make ISO 14971 more user-friendly and easier to understand with more guidance on key focus areas.Align with ISO 13485:2016, MDR, IVDR, and FDA emphasis on post-market surveillance.The main drivers for updating the standard were to: Manufacturers are expected to use the defined processes to establish objective criteria for acceptable risks and weigh them against the benefits the device provides. Risks related to medical devices and IVDs could be associated with: The standard, which also includes software and IVDs, applies to the entire life cycle of a product and describes processes for identifying hazards, estimating and evaluating the associated risks, and methods for controlling risks and monitoring the effectiveness of those controls. Published by the International Organization for Standardization (ISO), ISO 14971:2019 is the latest version of the standard that describes the application of risk management to medical devices. The fact is, if you manufacture medical devices or IVDs in any market, it’s important to understand ISO 14971:2019 requirements. IVD reclassification under IVDR is also forcing many manufacturers that used to self-certify to show evidence of compliance in their technical documentation. Not surprisingly, this has caused some confusion in the industry, especially since some notified bodies are using it as a reference. This is currently the case with ISO 14971:2019, which is not yet harmonized with the new EU MDR and IVDR regulations. However, there is often a gap between the time a new version is released and when regulatory organizations require compliance.

When new versions are released and harmonized, it’s up to manufacturers to learn about the changes to update systems accordingly. As the underlying risk management process for medical devices, the ISO 14971 standard is a critical component of regulatory and quality compliance.

Iso 14971 2007 free pdf