Before looking at some of these risks it is worth pointing out that many of these applications fall under the watch of local regulators. This ensures that certain criteria need to be met pre and post launch. These are mainly focused on patient safety but also mean certain activities may need to be carried out by the application owner.
According to definitions provided by regulators, such as the European Medicines Agency (EMA) and the Food & Drug Administration (FDA), a large number of these applications can be described as medical devices and will be regulated in the same way.
EMA DEVICE DEFINITION
“Any instrument, apparatus, appliance, software, material or other article, whether used alone or in combination, including the software intended by its manufacturer to be used specifically for diagnostic and/or therapeutic purposes and necessary for its proper application, intended by the manufacturer to be used for human beings for the purpose of:
- diagnosis, prevention, monitoring, treatment or alleviation of disease,
- diagnosis, monitoring, treatment, alleviation of or compensation for an injury or handicap,
- investigation, replacement or modification of the anatomy or of a physiological process,
- control of conception, and which does not achieve its principal intended action in or on the human body by pharmacological, immunological or metabolic means, but which may be assisted in its function by such means: ”In deciding whether a product falls under the MDD1, particular account shall be taken of the principal mode of action of the product.”
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For further information, please contact Adrian Donald, Head of Life Science and Specialty Chemicals on +44 (0)20 7528 4193 or email firstname.lastname@example.org