What a manufacturer needs to know about conformity assessment and declarations of conformity for IVDs
Information
Type
Guidance
Regulated products
IVDMD, Medical Devices
Topics
Manufacturing, In Vitro Diagnostic Medical Devices (IVDs)
Published
July 26, 2023
Last updated
March 27, 2024
Description
Depending on the classification of a device, there are a number of different conformity assessment procedures a manufacturer may use to demonstrate compliance.
Tags
Organization
Country / Region
Australia
License
Other (Non-Commercial)