Deep-dive into the classification systems and risk frameworks supported by DeviceCompass. Each guide covers scope, classes, key rules, timelines, and official references.
The primary EU legislation governing safety and performance of medical devices. Classification follows Annex VIII with 22 rules across four risk classes.
EU regulation for in vitro diagnostics. Replaces the self-certification model with risk-based classification requiring Notified Body involvement for most devices.
The U.S. FDA classifies medical devices into three regulatory classes based on the control necessary for safety and effectiveness, with distinct market pathways.
The internationally recognized standard for risk management throughout the medical device lifecycle. Uses severity, probability, and detectability scoring.
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