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PD CEN ISO/TR 20416:2020

Current
Current

The latest, up-to-date edition.

Medical devices. Post-market surveillance for manufacturers
Available format(s)

Hardcopy , PDF

Language(s)

English

Published date

08-19-2020

Publisher

British Standards Institution

This document provides guidance on the post-market surveillance process and is intended for use by medical device manufacturers.

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 ISO13485 and ISO14971. 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.

Committee
CH/210/6
DocumentType
Standard
ISBN
9780580971013
Pages
52
PublisherName
British Standards Institution
Status
Current

Standards Relationship
ISO/TR 20416:2020 Identical

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Hardcopy - English
PDF - English
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