European Commission Provides Important Guidance on Qualification and Classification of Software Under New Medical Devices Regulations
Data Matters
NOVEMBER 1, 2019
The Guidance seeks to provide clarification to medical software manufacturers with respect to (i) when software is considered a device (qualification) and (ii) what risk category the device falls into (classification). No clarification on “placing on the market.” This could have a significant impact for many software manufacturers.
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