By Stewart Eisenhart, Emergo Group
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:
- A four-tier system with Class A representing lowest-hazard devices and Class D the highest-hazard devices
- Classification determinations should be based on a device’s potential to harm a patient, its intended use and also the technology it uses
- Classification rules should be able to accommodate future technology developments
- Manufacturers should document their justifications for assigning their devices to Class A, B, C or D
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.
Stewart Eisenhart covers medical device regulatory affairs for Emergo Group.