It Could be Years Before Apple Watch 4's ECG Sensor is Approved for Use in the UK

By Tom Pritchard on at

One of the biggest announcements to come along with the Apple Watch 4 was that it includes an ECG sensor that can detect all sorts of things about your heart. The bad news is that this feature is only available in the US, because it needs regulator approval, and that means it could be years before Apple can offer that sort of thing on Apple Watches in the UK.

At least that's according to Medicines and Healthcare products Regulatory Agency, when 9to5Mac inquired about the possibility. Apparently the US FDA approved the Apple Watch 4's ECG sensor a single day before it was announced, and the site was wondering what it would take for it to receive similar approval over here. While the process itself isn't that complicated, the MHRA could go ahead and ask Apple to perform a study that proves the sensor's effectiveness. The downside is that studies Apple has already carried out won't be good enough:

You may need to carry out a clinical investigation as part of the process to obtain a CE marking for your medical device. You must inform MHRA if you are planning to do this at least 60 days before starting your investigation [providing] some basic details about the investigational device, the intended population, the type of study, and estimated application date.

So the MHRA needs to approve the study before it even gets chance to carry out the study - a process the MHRA says is the lengthiest (and most important) process. It has to be done properly after all, otherwise what would be the point?

The slightly better news is that Apple can bypass the MHRA through the EU, 9to5Mac points out that should the company gain approval in a separate EU member state, it would apply to the Union as a whole. In that situation the MHRA wouldn't necessarily be aware of preliminary approval, and it's already been suggested that the ECG sensor is close to being approved in Germany. Should that go through before the government pulls the country out of the EU, that would mean Apple doesn't have to go through the MHRA process and perform another study for the ECG sensor to be made available here. [9to5Mac]