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Category
Standard
Version
4
Access
Open
Status
Active
Updated
2018
This document outlines the principles and assessment criteria by which in-house in vitro diagnostic medical devices (IVDs) must be designed, developed, produced, validated and monitored for use by medical laboratories in Australia. The document addresses provision of appropriate resources, design, production, validation and continual monitoring of a device, including a device being used for purposes not intended by the manufacturer.

Main sections:

• General requirements

• Particular requirements – design

• Particular requirements – production and contracted services

• Particular requirements – analytical performance

• Particular requirements – scientific validity

• Particular requirements – clinical performance

• Particular requirements – clinical utility

• Particular requirements – multivariate index assays

• Particular requirements – monitoring, analysis and improvement

• Particular requirements – adverse event reporting and recalls of tests

• Particular requirements – documentation
Access Requirements for the development and use of in-house in vitro diagnostic medical devices (IVDs) v4

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