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Having shed light on the relevance of the intended purpose of a medical device when determining whether software qualifies as medical devices software (“MDSW”) under the new EU Medical Device Regulation 2017/745 (“MDR”) in part 2 of our series of articles, in this part 3, we now turn to the issue of risk classification of such MDSW under the MDR.

Software as a Medical Device in Europe – New Regulatory Regime About to Enter into Force – (Part 3 of 6)

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Software as a Medical Device in Europe – New Regulatory Regime About to Enter into Force – (Part 3 of 6)