GHTF Updates Definition of Medical Device, Adds Definitions for IVD, Device Accessory

The Global Harmonization Task Force’s (GHTF) Study Group 1 has modified its definition of a medical device and provided an explicit definition for the term in vitro diagnostic (IVD) medical device, according to a final document released May 16. The GHTF defines a medical device as “any instrument, apparatus, implement, machine, appliance, implant, reagent for in vitro use, software, material or other similar article intended by the manufacturer to be used alone, or in combination, for human beings, for one or more” specified medical purposes.
International Medical Device Regulatory Monitor