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). This is a broad category of software and the Guidance sets out that image optimizing means can be medical software.
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