ISO 14971:2019 – WHAT’S NEW?

Medical device manufacturers are now more responsible than ever for ensuring their products and devices offer the promised benefits and do not come with any unmanageable risks. Ordinances, laws and normative standards need to be observed when bringing medical devices into circulation, so that the devices are safe for patients, users and third parties.

ISO 14971 is one of the key standards for manufacturers of medical devices. This standard regulates risk management for medical devices. According to its specifications, effective and sustainable risk management needs to be performed to identify and resolve potential risks.

In December 2019, the third version of ISO 14971 was published and it brought with it a number of changes concerning application and new terms, for example.

Generally, it is important to note: ISO 14971:2019 is not harmonized. Changes for adjusting to the MDR may still be made in the future.

At the same time, the ISO/TR 24971 guideline was also revised; a number of annexes to the 14971:2019 edition were postponed in this report, making it more important now. However, ISO/TR 24971 is yet to be published.