Medtech Insight is part of the Business Intelligence Division of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

Australia Down Classifies Certain IVDs, Gives Labs New Conformity Assessment Route

This article was originally published in Clinica

Executive Summary

New rules in Australia have resulted in the down-classification of a small number of IVDs intended to detect certain pathogens and the introduction of an alternative conformity assessment procedure for laboratories that manufacture Class 4 in-house IVDs.