As it transforms into a new organization, the Global Harmonization Task Force (GHTF) continues to issue guidances likely to influence major medical device regulators worldwide.
In early October, the GHTF’s Study Group 1 published guidance on medical device classification principles. The guidance recommends a four-class system for medical devices based on intended use, and that should determine conformity assessment pathways for individual devices.
The guidance provides 17 rules for classification of devices, as well as decision trees demonstrating how to apply the rules.
Structural recommendations of the GHTF’s classification rules include:
In order to determine device classification, manufacturers should document their products’ intended uses and examine whether their devices fall under national rules that may impact classification in particular markets.