European Commission Provides Important Guidance on Qualification and Classification of Software Under New Medical Devices Regulations
Data Matters
NOVEMBER 1, 2019
However, the new classification rules set out in the MDR, in particular Rule 11, significantly change the classification of MDSW, with many software devices to be generally considered medium- or even high-risk devices. In the event of several rules applying to the same device, the strictest rule resulting in higher classification will apply.
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