Module 18 - Drug Device Combinations and Other Technologies

04/12/2023

Public

Notified Body Opinion

Report Format • Clear which version of the device has been evaluated • Clear to Competent Authority what has been looked at

Needs to contain sufficient detail to avoid duplication/ overlap of assessment • Any gaps in data need to be clear to Competent Authority

Copyright © 2022 BSI. All rights reserved

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Public

Notified Body Opinion Report

Copyright © 2022 BSI. All rights reserved

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