The International Organization for Standardization (ISO) has published a new standard and a new guidance document to aid medical device manufacturers, providing guidance on correct product information and effective monitoring of the device once it is on the market.
ISO 20417, Medical devices – Information to be supplied by the manufacturer, simplifies the process of meeting product information regulations by providing common generic requirements that are consistent across all devices in all geographical locations. The new standard will serve as a central source, thus reducing the likelihood of duplication and leaving specific product standards to focus more precisely on their unique requirements.
Technical report ISO/TR 20416, Medical devices – Post-market surveillance for manufacturers, provides guidance on effectively monitoring the safety, performance, and usability of the device in everyday use. This is essential to be able to spot any undesirable effects quickly, while also highlighting areas for improvement in safety, performance and usability.
Wil Vargas, committee manager of the ISO technical committee that developed the standards, said they are both aimed at helping manufacturers improve their products and meet all necessary laws and regulations in the most seamless and effective way.
“Through consulting with industry experts from all over the world, as well as considering the many regulations and other standards and guidance in this domain, we have done a lot of the legwork for manufacturers,” he said.
“These two documents, therefore, not only embody international best practice but help manufacturers adhere to national and regional regulations and recommendations such as those from the International Medical Device Regulators Forum, EU directives on medical devices and many other International Standards, including ISO 13485, Medical devices – Quality management systems – Requirements for regulatory purposes.”
ISO 20417 and ISO/TR 20416 were developed by ISO technical committee ISO/TC 210, Quality management and corresponding general aspects for medical devices, the secretariat of which is held by ANSI, ISO’s member for the USA. They are available from your national ISO member or through the ISO Store.