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ISO/AWI TR 20416

Medical devices — Post-market surveillance for manufacturers

General information

20.00     Jan 28, 2025

ISO

ISO/TC 210

Technical Report

Scope

This document provides guidance on the post-market surveillance process and is intended for use by medical device manufacturers. This post-market surveillance process is consistent with relevant international standards, in particular ISO 13485 and ISO 14971. This document describes a proactive and systematic process that manufacturers can use to collect and analyse appropriate data, to provide information for the feedback processes and use this to meet applicable regulatory requirements to gain experience from the post-production activities. The output of this process can be used:
— as input into product realization;
— as input into risk management;
— for monitoring and maintaining product requirements;
— for communicating to regulatory authorities; or
— as input into improvement processes.
This document 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. This document is not intended to replace or change applicable regulatory requirements for post-market surveillance.

Life cycle

PREVIOUSLY

PUBLISHED
ISO/TR 20416:2020

NOW

IN_DEVELOPMENT
ISO/AWI TR 20416
20.00 New project registered in TC/SC work programme
Jan 28, 2025