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). 6, 2 most software devices are classified as low risk. Key Points to Highlight. No change in qualification.
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