eu_mdr_compliance
Determine EU MDR classification and conformity assessment route for AI medical devices based on device details and intended purpose.
Instructions
Assess EU Medical Device Regulation (MDR 2017/745) compliance for AI-based medical devices. Determines MDR classification, conformity assessment route, and regulatory requirements.
Input Schema
| Name | Required | Description | Default |
|---|---|---|---|
| risk_class | Yes | Estimated risk class (Class I, IIa, IIb, III) or 'unknown' for classification assistance | |
| system_name | Yes | Name of the AI medical device | |
| intended_purpose | Yes | Intended purpose per MDR Article 2(12) | |
| device_description | Yes | Description of the device including AI/ML components |