Our review doesn’t test all of the claims an App Developer might make about what the App can or might do. Whilst for some Apps this isn’t a particularly onerous task, for others this would involve a huge amount of testing and trials to validate all aspects of safety and effectiveness.
For some Apps that fall within the definition of medical devices, this is something that they will potentially undertake as part of their certification as a medical device where – dependent on their classification – they will need to provide evidence to a Notified Body of the Apps compliance with specified standards.
Our Reviews aim to rapidly assess an Apps overall compliance levels with regulation, standards and best practice to provide a proxy view of whether it is something to engage with or not. High levels of compliance do tend to indicate a higher level of quality in the end product and vice versa.