MDCG 2021-24
Guidance on classification of medical devices
Official guidance on classifying medical devices under the MDR
- 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
The MDCG reference document. Provides a decision tree and worked examples for each classification rule, updated as new use cases arise.
Official sources
https://health.ec.europa.eu/system/files/2021-10/mdcg_2021-24_en_0.pdfSee where this text lands in your roadmap
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