The archive doesn't contain a direct comparison of FDA versus MHRA timelines for digital health approval. The chunks reference regulatory differences in scope and process rather than speed.
What emerges instead: the MHRA appears more cautious about defining digital health's regulatory category. One founder reports getting Class 1 medical device certification from MHRA in 2017 after navigating uncertainty about where clinical responsibility lies in doctor-free systems [#272]. Germany's DiGA process, by contrast, can take "a year or so" including clinical trials, but then grants marketplace access [#245]. The FDA gets more international deference—one developer notes FDA approval "helps dramatically" because other regulators accept it as a solid foundation [#442].
The real bottleneck isn't speed between agencies but regulatory clarity. The MHRA's database is described as "appalling" for finding products, and regulators are still "finding their feet" on what constitutes safe digital health [#399][#272]. Neither regulator has settled the fundamental question: how to regulate AI models as medical devices at all [#412].
If you're asking which pathway gets you to market faster, the archive suggests FDA approval carries more weight downstream, but doesn't directly measure one against the other.
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