The headline feature on the Apple Watch Series 4, from a technological and medical standpoint, is the presence of the electrocardiogram (ECG), which is a potentially lifesaving tool that can pick up signs of heart disease.
It’s the first over-the-counter device ever to feature the advanced technology, which measures the electrical activity of the heart using electrodes placed over the skin. In the case of the Apple Watch Series 4 it involves placing a finger on the Digital Crown for a few seconds to summon a reading.
In the United States this feature is approved by the Food and Drug Administration (FDA), meaning it’s a licensed medical-grade device. However, in the UK, the device does not have the requisite approval from the Medicines & Healthcare Products Regulatory Agency (MHRA). Unfortunately, it doesn’t appear to be coming any time soon.
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The MHRA said the process for approving an ECG includes a conformity assessment, which will induce an audit of the full quality assurance system. However, that won’t take too long.
What could cause a significant holdup is if Apple could be asked to carry out a clinical investigation, which would be designed to test the effectiveness of its device.
Unfortunately, the studies Apple has already carried out in the United States, would be unlikely to satisfy the MHRA.
“The last factor could be the most time consuming and could potentially add years onto the CE marking process,” the MHRA told 9to5Mac.
The saving grace for Brits hoping to make use of the feature, is the potential for a quick confirmation in Germany. Because the UK remains in the European Union right now, the study could be transferred to British authorities. In fact an additional source in Germany told 9to5Mac this may in fact be the case.
The Apple Watch Series 4 also includes features that inform wearers if their heart rate is particularly low, or irregular. These do not require medical approval and can be used simply to alert consumers to the trend.
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