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Register an AI System
The industry profile decides which fields, screens and rules apply. Under the medical profile one set of answers produces the EU MDR class, the IMDRF SaMD category and the FDA device class and submission pathway, because all three read the same two facts. You may override any proposal, and the override is recorded.
- 1Industry
- 2Intended purpose
- 3Classification
- 4Identity
- 5Confirm
Industry profile
Everything downstream follows from this.