Apple introduced the world to its Apple Watch Series 4 during their event a few weeks ago. This new version of the Watch brings some pretty big changes to the Watch. It not only features a new design, but it’s also bringing the new ECG feature directly to your wrist. This feature has been approved by the FDA in the United States, but if you live in the United Kingdom, you might have to wait several years to get it. That’s right – several years. The FDA approved the ECG on the Watch just one day before the launch of the wearable. The device itself boasts a 98% AFib detection, but that’s still not winning over anyone in the UK. While the approval process is not that complex, the Medicines and Healthcare products Regulatory Agency (MHRA) would like to examine Apple’s documentation before it gives its approval.
Why exactly? Well, it wants to make sure that the quality of the service is on par with the effectiveness and reliability of the feature. The time frame is 60 days for the MHRA to approve the study. If there are any questions regarding the study, the time would be stopped until an appropriate response is provided related to the issue. After the said time has passed Apple will be able to begin the study. This whole thing just seems like some paperwork needs to be reviewed, but the study itself could take a few years to complete.
This feature conceptually isn’t new. It’s been years in the making. In fact, it’s something that people have been asking about since Apple started measuring your heart rate a few years ago. So why wasn’t it tested in the UK at the same time that the FDA was testing it? This doesn’t exactly seem like Apple to just forget that they might have to go through testing in other countries. Further to that, Apple has carried out its own studies on the Watch’s performance in the United States, but the MHRA might not be satisfied with it.
As I mentioned, the process itself isn’t that complicated:
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.
Basically, the MHRA would look at the documents provided by Apple, and ensure that they’re satisfied with the quality of the ECG int he device. As mentioned above, that process could only take 60 days, but it’s the clinical testing that could take years. Which is more likely the case, as the documentation review doesn’t typically satisfy the MHRA. This is what could also hold up the process.
I’m actually very surprised that this is the case at all. I mean, the UK is a big market for Apple and they seem to have missed them completely. At least in regards to this service. Presumably, the Watch could be built without this feature and could be sold without it. And while there are a ton of new features in the Watch, this is a big one that a lot of people who are health conscious about, have been waiting for.