MDCG 2020-13
Clinical evaluation assessment report template
Template for the clinical evaluation assessment report
- Category
- MDCG guidance
- Market
- European Union
- Applicable classes
- Class IIa medical device, Class IIb medical device, Class III medical device
In practice
Recommended structure: device and indications, clinical data, analysis, conclusions. Following the template speeds up the notified body’s review.
Official sources
https://health.ec.europa.eu/system/files/2020-09/md_mdcg_2020_13_en_0.pdfSee where this text lands in your roadmap
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