Apple Watch 4 - ECG not in EU

Hmm… Up to now, I didn’t really needed an Apple Watch. But for my health (I am a heart patient) I am now interested in the Apple Watch 4 ECG feature. It could help me for tracking my heart issues.
So I wend to the local Apple store to pre-order. Unfortunately, they told me ECG will not work in EU until it gets approved (EU regulations).
They could not give me an estimation when, but it will not be this year, even next year is questionable. :-/

So, if you also are going to buy the Apple Watch 4 just for the ECG feature and you are living in EU …
Also, it is unclear if the Apple Watch 4 in EU will need to be replaced or a software update is needed. The Apple Store could not answer this question.

Well, they kept this a secret and now try to get approval in all the markets.

So buy it now and try it later.
Or maybe set locale to USA and get it sooner?

even in the US, the FCC approval is limited …
(in french) http://macbidouille.com/news/2018/09/14/des-medecins-ont-des-craintes-sur-le-systeme-delectrocardiogramme-de-lapple-watch

The people at the Apple Store could not confirm it’s merely a software limitation or hardware limitation. It is possible you will need another Apple Watch 4 watch later when it is approved.

Having a pacemaker myself (my second already) i would be interested in knowing which signals the watch would measure, my own nervesystem signals or those from the pacemaker. Last time i was for research at the cardiologist he said that it is very difficult to differentiate the signals. Personally i absolutely wouldn’t trust the results given by the watch.

  1. The Kardia Band by AliveCor - that does the same as the Apple Watch 4 - has long been approved for use in the EU.

  2. The FDA is considered a very tough institution, and if they approve something then it is usually approved in other markets too.

So I wouldn’t worry.

As for it possibly being a “hardware limitation”? Am I allowed to write bollocks?

I’m an old cynic. What do you think will happen when you come to your german doctor with your own ECG and tell him that there is something strange? For sure, those poor persons will scoff about some new-fangled nonsense. And yes, I know a lot of doctors - unfortunately.

You call THAT cynic? I know a lot off doctors too. Never met one who isn‘t happy about anything that brings them more business …

:wink:

[quote=405700:@Markus Winter]
2) The FDA is considered a very tough institution, and if they approve something then it is usually approved in other markets[/quote]

That’s not correct. The EU1935/2004 and the now EU1935/2011 is way more strick in regulations compared to FDA (I know … it’s my day time job: approving medicins for UZA).

Anyhow, the local Apple Store confirmed the ECG wil not happen this year. But they still cannot confirm if the watch needs to be replaced.

I think you need to wait for the Apple Watch 4 to be released, then try to figure out if the model number sold in the US is different from the EU.
If it is different then there may be hardware differences.
If both model numbers are equal, you can just hope it is a software limitation.

Perhaps even setting the watch locale to US will enable the feature.

The FDA has NOT approved the ECG feature in the Apple Watch… they have “cleared” it… there is a HUGE difference. As this article says, a “tongue depressor” is cleared by the FDA as well… The FDA only issues an approval on a Class III device, the Apple Watch is Class II (a tongue depressor is a Class I)

https://www.theverge.com/2018/9/13/17855006/apple-watch-series-4-ekg-fda-approved-vs-cleared-meaning-safe

My reading of this leads me to consider this a “novelty”… albeit one that might point to something worth discussing with your doctor, however if you have a heart condition where ECG is a required tool, then its best taken with more than “the equivalent of a lead one device”, which is all the Apple Watch is. (I’ve had it done with anywhere from 3 to 12 leads)

That’s how I feel about the watch. They’d sold me on a Series 3 because in the promo video it somehow magically helped a little girl with her diabetes. I never found out how it actually helped, there’s nothing there that makes it anything useful for diabetics. Sure, you can get an app, but how does that help any more than my current routine?

Apple, let me know when the watch links up with my CGM or - better yet - reads my sugar.

Side note, anyone want a Stainless 38mm Series 3 with Cellular? Black watch band has never been used (ordered a fancy one and it arrived before the watch did). Feel free to PM or email to negotiate :slight_smile: