Abstract

This Technical Report provides guidance on the relationship between EN ISO 13485:2016, Medical
devices – Quality management systems – Requirements for regulatory purposes and the requirements
in EU Regulation 2017/745 on Medical Devices and EU Regulation 2017/746 on in vitro Diagnostic
Medical Devices.

General Product Information

Published
Document Type	Standard
Status	Current
Publisher	British Standards Institution
Pages
ISBN
Committee	CH/210