It may take a lot more effort from Apple to get the ECG feature on the Apple Watch Series 4 approved for use in the UK as compared to the US, where it obtained FDA clearance just one day ahead of the launch.
The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has told 9to5Mac that it would first examine the documentation Apple supplies, and ensure that it is satisfied that the quality assurance system does indeed guarantee the effectiveness and reliability of the feature.
After that, however, Apple may also need to carry out a medical study to test the effectiveness of the AFib detection. Although one may think this would be simple enough as Apple has already carried out such a study and it could just provide that data to MHRA. Turns out it’s not enough to satisfy MHRA.
It requires companies to notify them in advance of an intention to carry out the study. The MHRA then has 60 days to approve the study. If it has any queries, the clock stops until it has received a satisfactory response to the issues raised.
Once that time has elapsed, Apple will be able to begin the study. Depending on the scale of the study and the period over which it is required to run, this could be an extremely lengthy process.
The last factor could be the most time consuming and could potentially add years onto the CE marking process.
On the other hand, a German cardiologist has revealed in an interview with Heise that the feature might come to Germany ‘relatively quickly’.
Apple has already said that it’s currently in the process of working with Health Canada to bring the functionality to the Canadian market.