ISO/TR 20416:2020 医疗设备 制造商的上市后监测

标准编号：ISO/TR 20416:2020

中文名称：医疗设备 制造商的上市后监测

英文名称：Medical devices — Post-market surveillance for manufacturers

发布日期：2020-07

标准范围

本文件提供了上市后监测流程指南，供医疗器械制造商使用。这种上市后监督过程符合相关国际标准，尤其是ISO 13485和ISO 14971。本文件描述了一个主动、系统的过程，制造商可以使用该过程来收集和分析适当的数据，为反馈过程提供信息，并使用该过程来满足适用的监管要求，从而从岗位上获得经验-生产活动。此过程的输出可用于:-作为产品实现的输入；-作为风险管理的投入；-用于监控和维护产品要求；-用于与监管机构沟通；或-作为改进过程的输入。本文件不涉及监管机构执行的市场监督活动。它也没有规定制造商因其生产或售后服务而按照适用的监管要求采取的行动-生产活动，也不向监管机构报告。本文件无意取代或更改上市后监管的适用监管要求。

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.

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