Apple Watch Series 4 users in the United Kingdom could be in for a long wait before they can make use of the wearable’s ECG feature.
9to5Mac contacted the Medicines and Healthcare products Regulatory Agency (MHRA) to ask how long the U.K. approval process might take, and the answer wasn’t encouraging.
While the approval process isn’t complicated, it could be lengthy. Apple could be asked to carry out a clinical investigation to test the effectiveness of the device’s AFib detection.
You might think that this would be simple enough, as Apple has already carried out such a study, so in principle could just hand over the data and the findings.
But this would likely not satisfy the MHRA. It requires companies to notify them in advance of an intention to carry out the study.
The MHRA would first examine any documentation supplied by Apple, to ensure that the quality assurance system guarantees the effectiveness and reliability of the feature.
Then the clinical investigation would take place. Although Apple has already carried out similar studies for FDA approval in the United States and could likely hand over those results, this might not satisfy the MHRA. The agency requires companies in advance of the intention to perform such testing.
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.
Once the 60 day period has passed, Apple would then be allowed to begin the study. Depending on how long Apple is required to run tests, this could be a lengthy process, possibly adding years to the approval process.
While it is possible that Apple may already have obtained permission to conduct a study, it could be years before U.K. users can see the ECG feature enabled.