The IVD regulatory framework has the following features:
● IVDs must comply with a set of essential principles for the quality, safety and performance of the IVD.
● A risk-based classification scheme requiring different levels of regulation for each class of device.
● There are a choice of procedures (known as conformity assessment procedures), based on the risk classification, to be applied by manufacturers to demonstrate initial and on-going compliance with the essential principles.
● Compliance with recognised standards is used as a means to demonstrate that the essential principles and conformity assessment procedures have been met.
● It includes provisions for post market activities, including monitoring and adverse event reporting.
Laboratories, the Therapeutic Goods Administration (TGA) and the National Association of Testing Authorities (NATA) are involved in ensuring the regulatory requirements of in-house IVDs are met.
This guidance explains how laboratories that manufacture in-house IVDs can meet these requirements.
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