Class I
The lowest risk category in the EU medical device classification. Devices in this class generally require only a manufacturer's self-declaration to be placed on the market, but must still satisfy clinical evidence and quality management system requirements.
Timeline (last 90 days)
Amblyotube is described as a "Class I medical-adjacent tool," part of the digital therapeutics lineage; it has not completed the medical device approval process, but it already has a clear therapeutic intent and mechanism design.
Class I is the lowest-risk category in the EU medical device classification, generally requiring only self-declaration for market placement, but still requiring clinical evidence and a quality management system.
All Facts (2)
Amblyotube is described as a "Class I medical-adjacent tool," part of the digital therapeutics lineage; it has not completed the medical device approval process, but it already has a clear therapeutic intent and mechanism design.
50%UnverifiedClass I is the lowest-risk category in the EU medical device classification, generally requiring only self-declaration for market placement, but still requiring clinical evidence and a quality management system.
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