The key feature of the Apple Watch Series 4 is the built-in ECG feature. While Apple warned that it should not be used as a replacement for professional grade medical equipment, the fact that you can walk around with an ECG strapped to your wrist does help users better track their health.
Unfortunately this feature is only available for those in the US, and for those in the UK or potentially other countries, it might be a while coming. 9to5Mac reached out to the Medicines and Healthcare products Regulatory Agency (MHRA) in the UK who see how long the approval process would take, and it seems that it could take a while.
According to the agency, “ECG devices for self-monitoring are classified as class 2a and the manufacturer will require a Notified body to carry out a conformity assessment. The most common assessment route is by audit of the full quality assurance system.” It doesn’t seem too complicated, but there is a possibility that Apple could be asked to carry out a clinical study to prove the device’s effectiveness, which in turn could take a while.
Now we’re sure that Apple has probably done all their homework so it is unclear as to how far along into the approval process they are, but given that different countries have different laws and requirements for such medical devices, it’s really anyone’s guess when the ECG feature will be enabled for all.
Filed in Apple Watch, Health, Legal, Smartwatch and Wearable Tech.. Read more about