What is the regulatory status of consumer wearables versus medical devices in RPM?

Consumer-grade wearables (e.g. Apple Watch, Fitbit) may generate clinically relevant alerts such as atrial fibrillation notifications, but they are not validated as diagnostic instruments. For clinical decision-making, devices must hold UKCA or CE marking and comply with Medical Devices Regulations. The MHRA classifies software processing physiological data for diagnosis or monitoring as a medical device in its own right.