DIN Standards Committee Health Technologies
Medical devices - Post-market surveillance for manufacturers
Abstract
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.
Begin
2025-01-30
WI
JT003076
Planned document number
prCEN ISO/TR 20416 rev
Responsible national committee
NA 176-01-02 AA - Quality management and corresponding general aspects for medical devices
Responsible european committee
CEN/CLC/JTC 3 - Quality management and corresponding general aspects for medical devices
previous edition(s)
Medical devices - Post-market surveillance for manufacturers (ISO/TR 20416:2020)
2020-08
