MDCG 2019-11
Guidance on qualification and classification of software
Qualification and classification of standalone medical software
- Category
- MDCG guidance
- Market
- European Union
- Applicable classes
- Class I medical device, Class IIa medical device, Class IIb medical device, Class III medical device
In practice
Determines whether software is a device and its class. Rule 11: software for diagnosis or prediction is class IIa at minimum; software driving treatment reaches IIb or III.
Official sources
https://health.ec.europa.eu/system/files/2020-09/md_mdcg_2019_11_guidance_qualification_classification_software_en_0.pdfSee where this text lands in your roadmap
Normiq places every deadline in your device's roadmap, with the steps that lead to it. Free 7-day trial.
Start the free trial