Australia Therapeutic Goods (Medical Devices) Regulations 2002 r3.2-3.3: Classify every device by its intended purpose under Schedule 2 (non-IVD) or Schedule 2A (IVD), applying the regulation 3.3 principles for combinations, accessories, software, production systems and packs

What does r3.2-3.3 require?

The manufacturer must work out the class of each device by applying the classification rules in Schedule 2 for ordinary devices or Schedule 2A for IVD and in-house IVD devices, guided by the device's intended purpose. IVDs are ranked by public health and personal risk (Class 1 no public health risk or low personal risk, up to Class 4 high public health risk). Devices used together are classified one by one, an accessory gets its own class, software that drives or influences a device shares that device's class, and a production system takes the class of the device it is meant to make. A device not confined to one part of the body is classified on its most critical use; where several rules apply the highest outcome wins. For systems and procedure packs, medicines are not treated as integral; a pack mixing IVD and non-IVD devices takes the higher class, or its primary purpose where the classes are equal. A rule added in September 2026 (Schedule 2 clause 2.2A, non-invasive devices) applies to new applications at once and to existing entries after five years.