Preamble

The goals of this meeting were to review a draft set of classification rules for IVDs, to discuss issues pertaining to in-house tests and home use tests, and to review a preliminary draft of Discussion Paper outlining the proposed framework.

Meeting discussions

The Working Group reviewed preliminary results from the laboratory small volume survey, and it was noted that a significant percentage of small volume tests are conducted using commercial tests that are currently exempt from listing or registration on the ARTG.

Members reviewed the report prepared by the Classification Sub-Committee, and there was general discussion on the proposed rules. It was agreed that justifications/ explanations for each rule should be prepared and included in the Discussion Paper. It was also agreed that all instrumentation would fall into Class I but that when a specific instrument was required for use with an IVD in a higher risk class, that the instrument would be assessed as part of the conformity assessment process for the IVD.

There was detailed discussion on in-house tests, and the Working Group finalised a definition for the term. It was agreed that while a National Pathology Accreditation Advisory Council (NPAAC) standard on in-house test validation could be used as an element of a regulatory mechanism, a range of additional options still need to be developed and considered.

Members reviewed a background document relating to the ongoing development of home use IVDs intended for use in the detection of serious disease markers, e.g., cardiac enzymes, cancer markers, tuberculosis, etc., and there was discussion around whether additional premarket controls are needed for these types of products. The TGA presented a modified evaluation process, and it was agreed that the TGA should seek advice on the issue of home use IVDs for serious disease markers from Departmental Policy Forum. A revised definition for home use IVDs was also finalised.

The Working Group reviewed a preliminary draft of the IVD Discussion Paper, and it was agreed that more contextual information is still needed. It was agreed that the Working Group would have the opportunity to comment on the paper again after all the comments received during the meeting had been incorporated.

Key outcomes

Outcomes of the meeting included:

• finalisation of definitions for "in-house test" and "home use IVD";
• agreement to proceed with developing additional options for the appropriate regulatory control of in-house tests;
• agreement on a draft set of classification rules for IVDs, and
• agreement to progress the Discussion Paper by including additional background information, explanations to support each classification rule and additional information about in-house tests.

Next meeting

It was agreed that a further meeting would only be organised prior to the Discussion Paper being finalised if needed.

Rita Maclachlan
Chair
8 November 2002