U.K. regulatory approval for Apple Watch ECG feature could take years. Ben Lovejoy reached out to the Medicines and Healthcare products Regulatory Agency.
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.
It turns out that Apple only got FDA approval one day before the keynote. It’s probable that Apple has been working with UK regulatory bodies all along, and that process just takes longer than here in the U.S.
Check It Out: UK Approval for Apple Watch ECG Could Take Years
