Apple is in no hurry to extend the function of an ECG in the UK
The portal 9to5Mac has applied to the British regulatory Agency medicines and drugs (MHRA) to find out what means and how long will the process of implementation of ECG by using smart watches in Britain.
“The device for personal an ECG classified as class 2A and the manufacturer will require that the competent authority of the state conducted a compliance evaluation standards,” – said the Agency. “The most common method of evaluation – audit of the full quality assurance”.
On paper, the audit system quality assurance Apple looks not very difficult, however, MHRA will also require clinical studies Apple, proving the effectiveness of the new sensor.
“Perhaps Apple will have to carry out a clinical study as part of the process of obtaining CE marking for Watch Series 4, as for medical devices. The company should inform MHRA if you decide to do this, at least 60 days before the start of the study, providing basic information about the DUT, the expected population, type of study and likely date of implementation” — said the Agency.
The implementation of these requirements will take Apple a lot of time, by the slightest of hiccups and misunderstandings will lead to more delays.
With so many complexities and bureaucratic nuances in the UK, where medicine is at a high level, it is easy to understand that in Russia a permit for the introduction ECG is no less time.
I find it hard to understand why you cannot add the ECG just as the function without official registration. How much inaccurate it was (which is unlikely), it’s still a safety net for people experiencing heart problems.
If you’ve read this article till end and share your opinion why bureaucracy hinders the safety of people’s health?