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> the watchdogs in at least 3 countries (France, Italy, Germany) are extremely helpful in navigating regulations This is a bad dependency to have. For example,
by robertlagrant 3y ago
> the watchdogs in at least 3 countries (France, Italy, Germany) are extremely helpful in navigating regulations
This is a bad dependency to have. For example, for the new EU medical device regulation, IVDR, a lot of the regulatory infrastructure just isn't ready[0], and many bodies are bowing out due to the complexity. Ironically, the British Standards Institute is one of the few notified bodies to take it on!
And that's medical devices, which are a tighter form of software. Regulating software in general seems like a very difficult task.
[0] https://www.degruyter.com/document/doi/10.1515/cclm-2021-0975/html https://www.degruyter.com/document/doi/10.1515/cclm-2021-097...
- orwin 3y agoYes, I think I was unclear: depending on local governmental watchdogs/agencies goodwill isn't a good solution. It's the one EU choose however. It's weird for Anglo countries, or countries with the Anglo law system, where the legislation might have holes and weak points, but decree and case law fill those holes (the French system work like that too). EU can't do that because it's a federation of countries with different culture and interest. Again, not saying it's good, I'm saying that's how it works.
- WA 3y agoI still wonder who enforces the MDR if a company from outside the EU offers their app/software to EU citizens without any certification. There are quite a few health apps that are considered medical devices under MDR, but not in other countries. The EU companies must comply with the regulations, but nobody seems to be responsible for removing non-certified apps made by non-EU companies. That is a huge competitive disadvantage for EU companies.