Medical Device Classification
The classification of medical devices in the European Union is outlined in Annex IX of the Council Directive 93/42/EEC. There are basically four classes, ranging from low risk to high risk.
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Classification of medical devices
The United States Food and Drug Administration (FDA) oversee European Authorized Representative (Non European) medical device companies that must comply with the Center for Radiological Devices and Health (CDRH) while selling medical devices in the US market. The FDA regulates EU representative (Non european country) medical device products and companies that manufacture, repackage, relabel or import medical devices sold in the United States.
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