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Have you seen new European Medical Device Regulation (MDR)? Especially classification rule 11 for software makes things interesting. Regulatory compliance is go
by kakoni 7y ago
Have you seen new European Medical Device Regulation (MDR)?
Especially classification rule 11 for software makes things interesting. Regulatory compliance is going to be difficult/costly for smes...
- jtwaleson 7y agoI was thinking the same thing. The regulation makes sense when purely looking at consumer/patient protection, but it really hurts competition and innovation. I would not be surprised if rule 11 gets revised. If you don't know: rule 11 states that all software that guides decision making on health issues is classified as higher risk. Basically any health related website or app is in scope and will need a certified quality management system. Very expensive to implement.
- ElFitz 7y agoOh my. Just when I thought of getting into patient management systems because every doctor and med student around me keeps complaining about those
- kakoni 7y agoYou still can. There is an exception to MDR rule that says; "Information systems that are intended only to store, archive and transfer data are not qualified as medical devices in themselves."