Medical Device Determination Skill

Purpose

Evaluate whether a product qualifies as a medical device under FDA, EU MDR, and MFDS regulations. This is a pure analysis unit that receives device information and returns a structured determination result.

Input: Device description, intended use, product form, primary function Output: Determination (YES/NO/CONDITIONAL), traffic light (GREEN/YELLOW/RED), applicable regulations Knowledge Base Date: 2026-01

Decision Framework

FDA (21 CFR 201(h))

Core question: Is the product intended for diagnosis, treatment, cure, mitigation, or prevention of disease -- without achieving its primary purpose through chemical action or metabolism?

Detail: See modules/fda-criteria.md

EU MDR (Article 2(1))

Core question: Is the product intended for a specific medical purpose as defined by EU MDR, including diagnosis, treatment, monitoring, or investigation?

Detail: See modules/eu-mdr-criteria.md

MFDS

Core question: Is the product used for disease diagnosis/treatment/prevention or structure/function examination/replacement/modification, without chemical action as primary effect?

Detail: See modules/mfds-criteria.md

Analysis Workflow

Step 1: Use Provided Device Information

Use the device information provided as input. Required fields:

• •Device description and physical characteristics
• •Intended use statement (medical purpose)
• •Product form (hardware, software, IVD, combination)
• •Primary function and mechanism of action

Minimum Determination Input Contract

Before issuing deterministic multi-region determination output (YES/NO/CONDITIONAL), the following minimum inputs must be explicit:

1. •Intended medical claim (what disease/condition is being diagnosed, treated, monitored, or prevented)
2. •Product mechanism and software role (display-only vs analysis/decision logic vs hardware control)
3. •Measured parameters and data source (e.g., FEV1/FVC/PEF and how those values are derived)
4. •Target patient condition and care context (including target patient condition: critical/serious/non-serious where applicable)
5. •Target market scope (FDA / EU MDR / MFDS, or subset)

If any critical input above is missing or contradictory:

• •do not output deterministic determination/classification/pathway conclusions
• •return an insufficiency rationale
• •ask 1-3 minimum follow-up questions that directly resolve missing inputs

Step 2: Apply Multi-Region Criteria

• •Evaluate against FDA, EU MDR, and MFDS definitions
• •For each region: determine YES/NO/CONDITIONAL
• •Reference modules/ for detailed criteria when deep analysis needed

Step 3: Assign Traffic Light & Escalation

• •GREEN: All regions agree on device status
• •YELLOW: Borderline or conditional -- escalate to expert
• •RED: Not a medical device in any region

Detail: See modules/escalation-traffic-light.md

Step 4: Return Structured Result

Return the determination result containing:

• •Multi-region determination (YES/NO/CONDITIONAL per region)
• •Applicable regulations per region
• •Traffic light assessment
• •Escalation flags if borderline

Data Source Strategy

1. •Built-in Knowledge (Primary): Embedded decision frameworks from FDA, EU MDR, MFDS regulations
2. •Module Files (On-demand): Detailed criteria in modules/ loaded when deep analysis needed
3. •MCP Connectors (Supplementary): Organization-specific regulatory data and verification

For MCP integration patterns (tool discovery, graceful degradation, source attribution), see CONNECTORS.md.