CEN ISO/TR 20416:2020

ISO/TR 20416 provides guidance on the post-market surveillance process. It provides guidance to manufacturers who are planning and executing their post-market surveillance activities. As medical devices are developed and manufactured for the global market, a residual risk regarding the medical device’s safety and performance remains throughout the product life cycle. Due to that, it is important to collect and analyse information on the medical device during production and post-production.

Post-market surveillance described in ISO/TR 20416 enables manufacturers to use collected data and information for product realization, risk management, communication to regulatory authorities or product improvement. Appropriate processes for collecting and analysing the information on the production and post-production feedback allow for early detection of any undesirable effects.

ISO/TR 20416 does not address market surveillance activities to be performed by regulatory authorities. Neither does it specify a manufacturer's actions required by the applicable regulatory requirements resulting from their production or post-production activities, nor reporting to regulatory authorities. The text of ISO/TR 20416:2020 has been approved in Europe as CEN ISO/TR 20416:2020 without any modification.