Final global device documents available on GHTF (Global Harmonisation Task Force) website:
This article was originally published in Clinica
Executive Summary
Final documents recently posted by Study Group 2 (SG2) of the Global Harmonisation Task Force on its website are as follows: manufacturers' trend reporting of adverse events; global medical device competent authority report; and medical device postmarket vigilance and surveillance: timing of adverse events reports. SG2 oversees documents concerning adverse event reporting, postmarket surveillance and vigilance. The reports are available at: www.ghtf.org/sg2/sg2-final.html