CEN ISO/TR 20416:2020

Medical devices - Post-market surveillance for manufacturers (ISO/TR 20416:2020) CEN ISO/TR 20416:2020

Publication date:   Nov 17, 2020

General information

60.60 Standard published   Aug 19, 2020


CEN/CLC/JTC 3 Quality management and corresponding general aspects for medical devices

Technical Report

11.040.01   Medical equipment in general



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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.

Related legislation

Legislation related to this standard


Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC

Life cycle


CEN ISO/TR 20416:2020
60.60 Standard published
Aug 19, 2020