The ECG feature is one of the main features of the Apple Watch Series 4, but as it turns out, getting it to market is a big challenge for Apple.
Not only did the company receive FDA approval in the United States literally hours before the September 12th reveal, but Apple is taking much longer to get approval in other countries.
The UK is one such example, and a report from 9to5mac revealed that it could take many months for Apple to bring ECG to the local market.
First of all, the Medicines and Healthcare products Regulatory Authority (MHRA) requires companies launching such devices to conduct clinical research before public release, and pre-study notification is required.
“You may need to conduct a clinical investigation as part of the process to obtain a CE marking for your medical device. You must notify the MHRA if you intend to do this at least 60 days before you start your investigation [providing] some key details about the investigational device, the intended population, the type of study and the estimated date of implementation,” according to the aforementioned source.
After the notification is sent, the agency has another 60 days to give the green light. The company can begin the medical study, which in turn can take up to several months.
Of course, Apple is well aware of all the steps it needs to complete before ECG is approved in each market, and there is a possibility that the company has already started working with global organizations on this matter.
However, ECG will launch first in the United States, with a future watchOS to bring the functionality to the Apple Watch Series 4. We don't know anything about the timeline, however.
