How does the MHRA classify software as a medical device?

The retrieved chunks don't address the MHRA's formal classification criteria for software as a medical device with any precision. What's evident from the archive is that the MHRA does classify software as medical devices and assigns it to risk classes (Class 1, Class 2A) [#252][#272], and that it operates under the MDR framework [#385]. One founder notes that transparency about intended use, limitations, and clinical indications matters to MHRA approval [#317].

But the chunks don't explain how the MHRA *determines* which software crosses into device territory versus remaining unregulated, or how it assigns risk classes. For a direct answer to your question, you'd want to ask specifically: "What criteria does the MHRA use to distinguish medical device software from general wellness apps?" or "How does the MHRA's risk classification system for software work in practice?"