THE MUCH-HYPED electrocardiogram (ECG) feature on the Apple Watch 4 could take “years” to get approval in Blighty.
The Medicines and Healthcare products Regulatory Agency (MHRA) explained to 9to5Mac that the feature, which can help detect heart issues, could face a tough battle gaining clearance in the UK, despite receiving Food and Drug Administration (FDA) approval in the US.
While the process doesn’t appear to be particularly complicated, the MHRA notes that afterwards, Apple would be required a new clinical investigation to judge the effectiveness of the ECG on the Apple Watch.
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 60 days in advance of a study, the agency adds.
“You may need to carry out a clinical investigation as part of the process to obtain a CE marking for your medical device,” the MHRA told 9to5Mac.
“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.”
The report notes that there is a “small possibility” that Apple already obtained the necessary approval to conduct its existing study. It also adds that, because the UK is still in the European Union, Apple would have the option of obtaining permission from the equivalent agency in another European country.
Still, if you’re looking to buy an Apple Watch simply because of its ECG functionality, you may want to hold off for now. µ
Source : Inquirer