If you're in the UK and you're wondering how long it can take before Apple can turn on the ECG feature on the Apple Series 4, the news does not look good.
Apple has been given permission to use the feature in the US just a day before the FDA launch, although Apple has not yet enabled it. But despite a study suggesting an accuracy rate of 98% when detecting AFib, Apple may face a much more difficult battle in obtaining a similar clearance in the UK …
I asked the medicines and care products regulator (MHRA) what it would have to do and how long the process would normally take.
The good news is that the process itself is not so complicated.
ECG self-monitoring devices are listed as 2a and the manufacturer requires a notified body to perform a conformity assessment. The most common assessment route is through the audit of the complete quality assurance system.
In other words, the MHRA would examine the documentation that Apple provides, and ensure that it is convinced that the quality assurance system indeed guarantees the effectiveness and reliability of the function.
However, Apple may also be asked to conduct a clinical trial & # 39; – or a medical examination – to test the effectiveness of the AFib detection. You might think that this would be simple enough, since Apple has already done research like this, so basically only the data and the findings could be handed over.
But this probably would not meet the MHRA. It requires companies to inform them in advance about the intention to carry out the research.
You may need to perform a clinical trial as part of the process to obtain a CE mark for your medical device. You must inform MHRA if you intend to do so at least 60 days before you begin your research [providing] some basic information about the research device, the target population, the type of research and the estimated application date.
The MHRA then has 60 days to approve the study. If there are any questions, the clock stops until it has received a satisfactory answer to the problems raised.
Once that time has passed, Apple can start the investigation. Depending on the scale of the research and the period over which it must run, this can be an extremely lengthy process.
The latter factor could be the most time-consuming and could potentially add years to the CE marking process.
There is a small possibility that Apple has already received the necessary approval to conduct its existing research. Although the MHRA is the official British body, because the UK is (for the time being) in the EU, Apple would have the possibility to get permission from the equivalent agency in another European country. The MHRA would not necessarily be aware of this.
But at this moment it seems likely that those in the UK and other European countries can wait for the Apple Series 5, 6, 7 or 8 before the feature is turned on …
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