Principle 14: Clinical evidence
Information
Type
Page
Regulated products
Medical Devices
Topics
In Vitro Diagnostic Medical Devices (IVDs)
Published
July 12, 2024
Last updated
July 12, 2024
Description
Principle 14 requires every medical device is supported with clinical evidence. The evidence must show the device meets the relevant Essential Principles.
Tags
Organization
Country / Region
Australia
License
Other (Non-Commercial)