Posted by Michael Wonder on 28 Feb 2017
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 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.
