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Can We Bring a Lifestyle Device to Market First?
Anonymous
updated about 1 year ago
We’re developing software as a medical device which might be class I or IIa under the MDR. Right now, we don’t want to go through all the regulatory pain and are wondering whether we can bring it to m
Accepted answer
Yes! With some limitations though. The most important one is that the product which you bring to market must not fulfil the definition of a medical d