Clinical evidence guidelines documents for medical devices

28 February 2017

This document is intended to provide guidance to manufacturers of medical devices (including in vitro diagnostic medical devices (IVDs)) on what constitutes clinical evidence and the process of clinical data generation and clinical evaluation to produce such clinical evidence.

The guidelines were developed in consultation with stakeholders, taking into account submissions received. A detailed summary of responses to submissions and amendments to the document is available for interested stakeholders.

The document takes into account requirements of the Therapeutic Goods Act 1989 and the Therapeutic Goods (Medical Devices) Regulations 2002, and aligns with international guidance documents including those of the Global Harmonization Task Force (GHTF) and the European Commission 'MEDDEVs' which are also based on the GHTF guidelines.

Clinical evidence guidelines: Medical devices

Further information

We are developing an education strategy to support the release of the Clinical evidence guidelines: Medical devices. Details of this will be released via this web page as they become available.