Principle 15: Principles applying to IVD medical devices only
Information
Type
Page
Regulated products
IVDMD, Medical Devices
Topics
In Vitro Diagnostic Medical Devices (IVDs)
Published
March 15, 2024
Last updated
August 1, 2024
Description
Principle 15 covers elements that apply to IVD medical devices. Manufacturers should hold evidence of performance evaluation studies to meet the requirements.
Tags
Organization
Country / Region
Australia
License
Other (Non-Commercial)