ECG Feature on Apple Watch Could Take Years to Be Approved in the United Kingdom

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Earlier this month, Apple unveiled the Apple Watch Series 4 with a new electrocardiogram (ECG) feature that measures the electrical activity of your heartbeat, providing you with a heart rhythm classification that can be shared with your doctor. The feature isn't out yet, but it will be limited to Series 4 models in the United States later in 2018.


Today, 9to5Mac shared a potential time window for the launch of the ECG feature in the United Kingdom. The Medicines and Healthcare products Regulatory Agency (MHRA) explains that the process starts by examining Apple's documentation surrounding the ECG feature and performing an audit of the quality assurance system.

While this step doesn't appear to be lengthy, the proceeding steps could make the process longer. MHRA says it would require Apple to perform a new clinical investigation to judge the effectiveness of the ECG on Apple Watch, but Apple would likely not be able to use any of the data from the studies it's already completed because MHRA requires companies to notify the regulator in advance of a study.

Once the study is submitted, MHRA has 60 days to approve it (which may become longer if the regulators have further inquiries for Apple), and then Apple can begin the study. These last few steps are what the MHRA say "could potentially add years" onto the debut of the ECG in the UK.
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.

The last factor could be the most time consuming and could potentially add years onto the CE marking process.
Despite the potential for years-long approval, Apple may find ways to expedite this process. While the United Kingdom remains part of the European Union, it's possible that Apple could receive approval from a broader regulatory body and sidestep the MHRA's processes.

In the United States, Apple has obtained de novo FDA clearance for the ECG feature in the Apple Watch Series 4 and the feature that can send a notification if an abnormal heart rate has been detected. However, FDA clearance is not the same as FDA approval and the FDA does not recommend that the ECG feature be used by those under 22 or those who have already been diagnosed with atrial fibrillation.

The FDA warns that Apple's ECG app is not designed to replace traditional methods of diagnosis or treatment and is intended for informational use only.

Elsewhere, Apple has said it is working with Health Canada to bring the ECG functionality to the Canadian market, although no timeline has been specified.

Article Link: ECG Feature on Apple Watch Could Take Years to Be Approved in the United Kingdom
 


MrGimper

macrumors 603
Sep 22, 2012
6,101
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Andover, UK
This isn't surprising.... TBH I have no need for the ECG and suspect the majority of people don't. I appreciate there are some totally legitimate situations where it would be great, but for most of us it's a cool gimmick to show your friends.

The ECG wasn't part of my thought process when I upgraded from S2.
 

Sasparilla

macrumors 65816
Jul 6, 2012
1,296
1,962
Anything with health care is going to be slow - getting the approvals and tests, which as we've seen from Theranos are probably a good idea.

I'm still surprised Apple got the FDA to allow it in the U.S. so quickly - although maybe that's been in the pipeline a long time.
 

applepuree

macrumors 6502
Aug 15, 2014
367
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Medicines and Healthcare products Regulatory Agency just want their palms greased. Europe is famous for waisting time via regulations. Nothing like log jamming a digital watch feature.
Except this isn't the EU, its the UK they were talking about. Even if they could sidestep the UK regulations by getting in cleared by the EU, that type approval would probably be null and void when the UK leave the EU next march.

Any word on when/if EU approval might come (specifically Germany)?
 

buzzman

macrumors member
Aug 11, 2007
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I live in Switzerland and that could take a long time too here to be approved.
I'm wondering if there will be some sort of OS flashing from the US version to my Swiss watch. Guess we have to wait.
 
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cmaier

macrumors G5
Jul 25, 2007
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Except this isn't the EU, its the UK they were talking about. Even if they could sidestep the UK regulations by getting in cleared by the EU, that type approval would probably be null and void when the UK leave the EU next march.

Any word on when/if EU approval might come (specifically Germany)?
It is unlikely that brexit would nullify it. They need to keep continuity and can’t just unwind everything that has been approved in the last several decades.
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I live in Switzerland and that could take a long time too here to be approved.
I'm wondering if there will be some sort of OS flashing from the US version to my Swiss watch. Guess we have to wait.
It’s the same OS but will use location checks, assuming it is anything like what already happens for regional features.
 
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friednoodles

Suspended
Feb 4, 2014
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Why is everyone assuming Apple isn’t already months into this process like they were with the FDA?

Pretty sure they already know what’s involved with getting regulatory approval in their main markets. It’s not like they woke up the day after the keynote and thought “oh, maybe we should start doing stuff for other authorities now, why didn’t we think of this earlier?”
 

Bornee35

macrumors 6502
May 6, 2013
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Except this isn't the EU, its the UK they were talking about. Even if they could sidestep the UK regulations by getting in cleared by the EU, that type approval would probably be null and void when the UK leave the EU next march.

Any word on when/if EU approval might come (specifically Germany)?
Never said EU, just generalized Europe as a whole for waisting time on bureaucracy.
 

Absrnd

macrumors 6502a
Apr 15, 2010
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711
Flatland
I see 3 options:

- Apple is able to speed up de process, and will be added to Euro watches this or next year.
- it will never be released for Euro watches.
- still be able to use it with a US account workaround :) (my hope)
 

Khedron

macrumors 68000
Sep 27, 2013
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Medicines and Healthcare products Regulatory Agency just want their palms greased. Europe is famous for waisting time via regulations. Nothing like log jamming a digital watch feature.
If you want to claim health benefits for a product the rest of the world requires you back up that claim. The USA only requires your product doesn't actively hurt the user.
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This timeline is absurdly long. When I asked Health Canada on twitter they said that for a device like that they could approve an application very quickly, as quickly as 15 days. No reason why it should take years in UK.
And half of that time is probably waiting for testing fees to clear. Just imagine how thorough a scientific study can be performed in a week.