Category D
Autonomous decision management
What solutions are category D?
These are digital autonomous treatment solutions with automatic adjustment without requiring human intervention.
Is medical CE marking required?
Solutions in this category that have an impact on a therapeutic decision are necessarily CE marked.
Target users
Medical devices in this category are intended for use by the patient.
Existing funding
As these are solutions for therapeutic purposes, this category of self-treatment solutions meets the criteria for inclusion onthe LPP in the same way as non-digital medical devices.
Examples
One example in this category is a system that analyzes data from a continuous glucose monitor used by a diabetic patient and will automatically adjust the basal rate of insulin or administer a bolus of insulin without the patient's intervention (artificial pancreas, also known as a closed loop).
Artificial pancreas (closed loop)
We consider the algorithm that analyzes data from a continuous glucose monitor used by a diabetic patient and will automatically adjust the basal rate of an insulin pump or trigger a bolus of insulin without the patient's intervention.
Cardiac defibrillator
We consider an implanted cardiac defibrillator that analyzes cardiac activity and delivers a shock in the event of cardiac arrest or rhythm disorder, which then generates an alert that is transmitted to another solution (e.g. remote monitoring).