Apple Watch Series 4's ECG could potentially take years to approve in other countries

Ro, 27 September 2018

Undoubtedly, the coolest feature of the new Apple Watch Series 4 is its ECG monitor. However, the function will be available only for US customers later this year and maybe Canada in the future. But what about the rest of the world?

It's pretty disappointing to own such high-end and expensive piece of tech and being unable to use it to the fullest, so Apple fans around the world would be eager to know when the feature would be approved by their local authority.

Unfortunately, things look grim as 9To5Mac talked to UK's Medicines and Healthcare products Regulatory Agency (MHRA) about this and they said the process is simple but time-consuming. Apple would have to conduct a medical study and inform the MHRA 60 days in advance. Then the agency has 60 days to approve the study and allow Apple to carry it out. Depending on the scale of the study, it could potentially take months to years to complete.

But there's a silver lining to it - since the UK is still in the EU, if the ECG monitor is approved by the MHRA, the license could apply to other equivalent agencies in the rest of the European countries as well. Interesting fact - Apple got the FDA approval in the US just a day before the announcement of the watch.

So if you are looking to buy the watch solely because of the ECG functionality, you may want to stay put for now. By the looks of it, it may not come before the next gen rolls around.



Reader comments

  • Paul

Why does it need to be approved ? It isn't accurate anyway just like the heart BPM which is also just an indication and that wasn't approved neither. Apple should just activate this with the notion that it is just a best effort indication discl...

it was ready to come in microsoft band 3 already some time before, should not take so much time.

Seriously, people think this ECG gimmicks are real? You never accurately will see your heart cardiogram or whatever with this tiny device, you need a proper equipment for that, I can't believe people blindly believes everything what Apple throws to t...

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