This consultation closed on Friday, 11 December 2020.
The International Medical Device Regulators Forum (IMDRF) working group on Medical Device Clinical Evaluation (MDCE) has updated a previous document from the Global Harmonisation Task Force (GHTF) on Post Market Clinical Follow-up (PMCF) Studies. This is designed to promote global harmonisation around understanding and use of PMCF studies. The working group chair is Dr Yinghui Liu (China).
This draft IMDRF document is part of a series on Clinical Evaluation and aims to strengthen the role of PMCF studies in meeting evidence requirements regarding the Essential Principles and improving risk management throughout the lifecycle of medical devices. It provides guidance regarding: circumstances where a PMCF study is indicated; general principles of PMCF studies; design and implementation of PMCF studies; and the use of information from PMCF studies.
The Department of Health and Aged Care acknowledges First Nations peoples as the Traditional Owners of Country throughout Australia, and their continuing connection to land, sea and community. We pay our respects to them and their cultures, and to all Elders both past and present.