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

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.

applewatchseries4ecgfeature
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.

Related Roundup: Apple Watch Series 6
Buyer's Guide: Apple Watch (Neutral)
Related Forum: Apple Watch

Top Rated Comments

kingjames1970 Avatar
34 months ago
Maybe being dim here - but could they not just have massive disclaimers saying the readings aren't regulated/approved and are advisory only? See a doctor etc.
Score: 35 Votes (Like | Disagree)
friednoodles Avatar
34 months ago
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?”
Score: 35 Votes (Like | Disagree)
Bornee35 Avatar
34 months ago
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.
Score: 26 Votes (Like | Disagree)
826317 Avatar
34 months ago
It makes sense. This is a very serious feature that needs to be thoroughly tested.
Score: 25 Votes (Like | Disagree)
centauratlas Avatar
34 months ago
It is amazing that the UK government has to treat its citizens like babies who can't be trusted to make decisions for themselves. How about giving people the freedom to decide they want to use it or not? Sure, if they need to have a ton of disclaimers, go ahead.

It isn't as if this is a defibrillator that is going to try and shock your heart back into rhythm, it is another tool that could potentially save someone's life by recording an ECG/EKG to show to their doctor later. It isn't perfect no doubt since it is an early version, but give people the freedom to choose for themselves whether to use it. I know plenty of people who are competent enough to understand the limitations.

Talk about heavy-handed, paternalistic interference in people's lives.
Score: 15 Votes (Like | Disagree)
keysofanxiety Avatar
34 months ago
As someone else here stated, these regulatory bodies do not want patients using this information for self diagnosis to then go and waste very very tight resources in their specific regions, especially the UK, which there are waiting lists months and months long to just see a doctor.
That really isn't true. Do you have a citation for this which isn't the Daily Mail?
Score: 14 Votes (Like | Disagree)

Top Stories

apple watch ecg

Apple Watch Likely to Gain Blood Pressure, Blood Glucose, and Blood Alcohol Monitoring

Monday May 3, 2021 4:03 am PDT by
The Apple Watch may gain the ability to measure blood pressure, blood glucose, and blood alcohol levels, according to newly-revealed information about one of Apple's chosen business partners. Apple has been revealed to be the largest customer of the British electronics start-up Rockley Photonics, The Telegraph reports. Rockley Photonics has developed non-invasive optical sensors for...
airtags teardown tile mat galaxy smarttag

iFixit Shares AirTag Teardown Revealing 'Impressively Compact' Design Compared to Tile Mate and Galaxy SmartTag

Sunday May 2, 2021 4:54 am PDT by
iFixit has shared the first of its two-part series in tearing down Apple's AirTag item tracker, revealing that Apple had to make impressive design decisions to achieve its small design, including rethinking the speaker layout. For comparison, iFixit compared Apple's AirTag to the Tile Mate and the Samsung Galaxy SmartTag. Compared to the competition, AirTag is the smallest in size, with the...
facebook instargram updated att prompt 1

Facebook and Instagram Ask Users to Enable App Tracking in Order to Keep Services 'Free of Charge'

Sunday May 2, 2021 1:22 pm PDT by
As a way to convince users to enable tracking across other apps and websites, Facebook is deploying the tactic of telling users that they must enable tracking as part of the App Tracking Transparency framework in iOS 14.5 if they want to help keep Facebook and Instagram "free of charge." App Tracking Transparency or ATT is the newest privacy feature to come to iPhone and iPad devices as part ...
Flat 2021 MacBook Pro Mockup Feature 1

Mini-LED Display Production Improving for Redesigned MacBook Pro Models Later This Year

Monday May 3, 2021 8:33 am PDT by
Apple supplier TSMT, a key vendor involved in the production of mini-LED displays in the newly announced 12.9-inch iPad Pro, has been able to address technical challenges for the production of mini-LED displays to be used in the upcoming 14 and 16-inch redesigned MacBook Pro models. As reported by DigiTimes, TSMT had initially been facing production constraints with the circuit board and...
Foldable iPhone 2023 Feature Yellow

Kuo: Apple to Launch 8-Inch Foldable iPhone in 2023

Sunday May 2, 2021 8:43 pm PDT by
Apple is working to launch a foldable iPhone with an 8-inch QHD+ flexible OLED display in 2023, Apple analyst Ming-Chi Kuo said today in a note to investors that was seen by MacRumors. Based on our latest industry survey, we forecast that Apple will likely launch a foldable iPhone with an 8-inch QHD+ flexible OLED display in 2023, with SDC as the exclusive display supplier and Samsung Foundry...
iOS 14 on iPhone feature emergency

Apple Releases iOS and iPadOS 14.5.1 With Fixes for App Tracking Transparency Bug, WebKit Security Issues

Monday May 3, 2021 10:04 am PDT by
Apple today released iOS and iPadOS 14.5.1, minor security updates that come just a week after the release of the iOS 14.5 update. There is also a companion watchOS 7.4.1 update for Apple Watch and an iOS 12.5.3 update for older iPhone and iPad devices that don't support Apple's latest operating system versions. According to Apple's release notes, the update fixes a bug with App Tracking...
General Music and AirPod 3 Feature

Rumor: Apple to Announce Third-Generation AirPods and HiFi Apple Music Tier in 'Coming Weeks'

Saturday May 1, 2021 3:57 am PDT by
Citing sources within the music industry, Hits Double Daily reports that Apple is preparing to launch a new HiFi Apple Music tier in the "coming weeks," which will come alongside the release of the rumored third-generation AirPods. According to the report, the new tier, which will offer high-fidelity music streaming, will cost the same $9.99 monthly subscription as the current individual...
Top Stories 58 Feature 1

Top Stories: iOS 14.5 Released, AirTag Launch, New iMac and iPad Pro Pre-Orders

Saturday May 1, 2021 6:00 am PDT by
After nearly three months of beta testing, Apple this week finally released iOS 14.5, the company's biggest update since the iOS 14 launch last September. One of the main new features included in the update is support for AirTags, Apple's item trackers that also finally became available this week some two years after their existence first leaked. Apple this week also began taking orders for...
tile sticker e1570533758981

Tile CEO: 'We Welcome Competition From Apple, But We Think It Needs to Be Fair'

Tuesday May 4, 2021 9:51 am PDT by
Just after Apple announced its AirTags, Tile CEO CJ Prober relayed his concerns about competing with Apple in the tracking space, and said that Tile would ask Congress to investigate Apple's business practices specific to Find My and item trackers. Prober this week did an interview with Bloomberg, where he further expanded on Tile's complaints about Apple and why he feels that Tile is...
apple music album cover art

iOS 14.6 Beta 1 Code Hints at Upcoming HiFi Apple Music Support

Saturday May 1, 2021 10:41 am PDT by
Apple is laying the groundwork for adding HiFi support to Apple Music which would offer Apple Music subscribers and owners of compatible devices, such as certain models of AirPods, access to high-fidelity audio streaming, according to code within the iOS 14.6 beta discovered by MacRumors. Earlier today, a report claimed that Apple will announce a new $9.99 per month Apple Music tier that...