I specified all three via comma to highlight that we had quite some history in compliance, in different jurisdictions.
HIPPA covers only medical devices, GDPR covers everything. FDA approval process is convoluted and expensive, especially for new types of devices, but it's still much easier than European MDR.
Also, I mentioned FDA because we didn't even try to get a proper compliance in the EU, because it's impossible for a startup without huge support.
No, HIPPA covers only medical information. Perhaps with your organisation, this was restricted to devices, but within a hospital environment there's a lot more covered by HIPPA than just medical devices.
> but it's still much easier than European MDR
While MDR doesn't cover everything, it's still only 123 articles long: https://eur-lex.europa.eu/eli/reg/2017/745/2026-01-01. I'm guessing the burdensome parts are in SECTION 2: Conformity assessment – but I haven't found the unreasonable bit yet. So far it just seems like "do actual science to determine safety" and "if there's no 'intended medical purpose', also do actual science to demonstrate efficacy". There obviously are problems, as described in https://ec.europa.eu/info/law/better-regulation/have-your-sa..., but I don't see how the law-as-written results in these problems. (Maybe they didn't grandfather existing devices in? But that shouldn't affect a new device.)
Could you give us a run-down of the problems you faced before giving up, or link to a representative write-up, please?
I'll note that of the three regulatory acronyms you gave, two of them (HIPPA and FDA approvals) are American.