Dedicated

Being dedicated to the heart or central circulatory system moves certain invasive devices to class III. A general-purpose device that can be used there is not dedicated.

‘Dedicated’ means that the intended purpose of the device or accessory is to specifically control, diagnose, monitor or correct a defect of the heart or of the central circulatory system.

MDCG 2021-24 Rev.1, Section 4.2, Rule 6, Practical issues of classification, Note 3