Apple announced the Apple Watch Series 4 and grabbed the public’s attention with its new design and features, which includes a brand new Electrocardiogram (ECG) testing feature built into the smartwatch.
But while Apple was more than willing to talk about the feature and its impending launch in the United States following approval by the FDA, there was some pause when it came to announcements for international markets. Specifically, there will be a potentially significant waiting period before the ECG testing feature arrives outside of the United States. We know that Apple is working with entities in other countries, like Health Canada, to speed up the process, but there is no telling when the feature will arrive in those other markets.
Now, 9to5Mac has a report out on Thursday that outlines why the wait for the ECG testing feature in the United Kingdom might be even longer than some might expect. It could take years, in fact, according to a regulator. When the Medicines and Healthcare products Regulatory Agency (MHRA) was asked how long the approval process might take and what might be involved, this was their response, in part:
“ECG devices for self-monitoring are classified as class 2a and the manufacturer will require a Notified body to carry out a conformity assessment. The most common assessment route is by audit of the full quality assurance system.”
What might slow things down along the way is further testing. While Apple has obviously already conducted tests in the United States related to the ECG testing feature, and other health-related areas of the Apple Watch Series 4, the MHRA will likely not accept the documentation and findings from those earlier tests, relying on its own separate tests for the new hardware device:
“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.”
If all that does go well, the agency has up to 60 days to process the information and make a recommendation. However, if they determine that they need some follow-up questions regarding the findings or device itself, then the countdown stops and the agency can take its time for further investigation.
Next, the actual testing itself on Apple’s part, which could be the longest part of the whole process:
“The last factor could be the most time consuming and could potentially add years onto the CE marking process.”
It isn’t known where Apple is in this particular timeline. The company may have already jumped over the majority of these perceived hurdles in its goal to launch the ECG feature within the United Kingdom. Indeed, it’s likely that Apple has done most of the legwork already for the international markets where the ECG feature is even capable of launching.
Still, the potential reality is that the ECG testing feature may not be available in the UK anytime soon, which is certainly unfortunate news.