Customers in the United Kingdom could be waiting “years” for the new electrocardiogram (ECG) feature on the Apple Watch Series 4 to be approved and released according to a report citing the Medicines & Healthcare Products Regulatory Agency (MHRA).
Speaking to 9to5Mac, a spokesperson for the regulatory agency shared an insight into the process Apple will need to follow to receive approval to launch the ECG feature within the UK, revealing that the lengthy process could force the company to undertake new clinical investigations which could “potentially add years onto the CE marking process”.
It appears the clinical trials and documentation provided by Apple to gain FDA approval in the United States will be completely invalid in the United Kingdom, with Apple in many respects having to start from square one.
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 explains. – 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.
One potential way Apple could avoid this substantial delay would be to apply for approval from another regulatory body in the European Union, which would cover Apple Watch for the United Kingdom, too (while the UK. is still in the E.U.).
So far, Apple hasn’t announced when the new ECG feature on Apple Watch Series 4 will arrive in the United States.