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1) Scope & Device Description
2) Equivalence
3) State of the Art (SOTA)
4) Similar Devices
5) Device Claims
6) Literature Search, Vigilance Search and Appraisal Plan
7) Clinical Investigation
8) Article 61(10) under MDR
9) Stratification of Data & Analysis
10) Benefit / Risk Assessment
11) Updates & Other Considerations
12) Evaluator & Competences
