What is ISO TR 20416:2020 about?
Post-market surveillance is the process by which manufacturers collect and analyse data which can subsequently be used for product realization, risk management, communicating to regulatory authorities or product improvement. ISO TR 20416:2020 is a new international technical report giving guidance on how best to collect and analyse post-market medical devices surveillance data.
Who is ISO TR 20416:2020 for?
This document is for medical devices manufacturers planning and executing post-market surveillance as well as medical devices regulators.
The guidance in ISO TR 20416:2020 can also be useful to medical devices importers and distributors, and to reprocessors connected to the manufacturer in the lifecycle.
Why should you use ISO TR 20416:2020?
It helps to establish a common understanding of post-market surveillance by describing a proactive and systematic process that manufacturers can use to collect and analyse appropriate data. This process is consistent with relevant international standards, in particular ISO 13485 and ISO 14971.
The output of this process can be used as input into risk management, for monitoring and maintaining product requirements, for product realization, communicating to regulatory authorities, and for input into improvement processes.
ISO TR 20416:2020 will help manufacturers meet applicable regulatory requirements on gaining experience from post-production activities.
NOTE: ISO TR 20416:2020 does not deal with 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. This document is not intended to replace or change applicable regulatory requirements for post-market surveillance.