Classification of medical devices that are not IVDs

Note: This document does not include guidance on:

• whether your product is a medical device. See Confirm your product is a medical device that needs to be included in the ARTG
• boundary and combination products. See Boundary and combination products
• classification of in vitro diagnostic (IVD) medical devices. See Classification of IVD medical devices
• medical devices intended to be supplied sterile
• medical devices with a measuring function.