A method for the classification of digital health architectures as medical devices; a digital health research perspective

It is typical for many digital health research projects to develop IT architectures that will implement integrated care services that may also deliver interventions. As part of compliance with the requirements of the regulation, the components that are considered as a medical device will need to be classified to a medical device category. This is often seen as task that may increase the business risk and a major barrier of the project, particularly during the earlier stages when not all information is available. The paper offers a method assisting with classification of such architectures in the context of the Medical Devices Rregulation, offering a structured way to identifying how the initial deliverables of a project can be used to provide assurance to the justification of the classification.