Integrated or incorporated diagnostic function

Rule 22 puts active therapeutic devices with such a function into class III when the function significantly determines patient management. Closed-loop systems such as automated external defibrillators are typical examples.

‘Integrated or incorporated diagnostic function’ means the functionality of a system including a physiological sensors e.g. the AED electrodes/pads using a feedback control to process and record changes in the patient’s physiological state to continuously adjust a therapy. The diagnostic function can be physically integrated or a component of an external sub-system.

MDCG 2021-24 Rev.1, Section 4.2, Rule 22, Practical issues of classification, Note 1