Earlier this month, Apple introduced the Apple Watch Series 4 with a new ECG feature. However, the associated ECG app is not yet available because the corresponding approval for the functionality is missing in the respective countries. In the US, the CA has already given the OK, so the feature will be available in the US later this year. However, Apple is working intensively on the approval in other countries. 9to5Mac has taken a closer look at the certification process in the UK and concludes that the release could take several months to complete.
ECG certificate in the UK
When will the ECG App for the Apple Watch be unlocked? 9to5Mac’s colleagues did not want to wait long for Apple’s official announcement, and promptly in the UK asked the Medicines and Healthcare Regulatory Authority (MHRA).
As the MHRA explains, the review process starts with checking the Apple documentation for the ECG feature. Furthermore, the quality assurance system is checked to ensure that the function works reliably.
Although the first step does not seem lengthy, further steps could significantly extend the approval process. MHRA claims that Apple needs to conduct a clinical trial to demonstrate the effectiveness of the Apple Watch ECG. The authority has 60 days to approve a study. If she has questions, the clock will stop until she has received a satisfactory answer to the problems raised. After approval, Apple may begin the trial. Depending on the size of the study and the period over which it has to be carried out, this can be a very lengthy process.
In the case of the Apple Watch, however, Apple has already carried out a corresponding study in advance. Thus, there is a chance that one can use the already existing results. However, the authority will not be enthusiastic about this approach. For example, the MHRA prefers companies to inform the Authority in advance of the intention to conduct a study so that the matter can be considered during the said 60 days. Thus, the waiting time (at least in the UK) stands and falls with the goodwill of the authority. If Apple’s preliminary work is accepted, we can expect to see it implemented within the next few months. However, if a new study is needed again, the process could take much longer.
