The International Standards Organisation (ISO) has now published Technical Report ISO/TR 20416, ‘Medical devices – Post-market surveillance for manufacturers’.
The ‘Scope’ of the document explains:
“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.”
As a Technical Report, the document is unlikely to be harmonised under the Medical Devices Regulation (MDR, 2017/745), but will no doubt be used by notified bodies as a representation of ‘best practice’ for compliance with MDR requirements for post-market surveillance (PMS).