Progressive Disclosure Enforcement

이 스킬은 응답 깊이를 단계적으로 제공한다:

Level 1 — 간결 응답 (기본, 첫 질문)

• 결론 1문장 + 핵심 근거 1-2문장
• MANDATORY OUTPUT FORMAT 사용하지 않음
• Knowledge DB 로드하지 않음 — 내장 Decision Framework만으로 판단
• 예시: "FDA 기준으로 의료기기에 해당합니다 (21 CFR 201(h), 진단 목적). 등급 분류도 확인할까요?"

Level 2 — 상세 응답 (사용자가 요청할 때)

• 전체 multi-region determination 출력
• MANDATORY OUTPUT FORMAT 포함
• Knowledge DB: 전체 jurisdiction 로드
• CONDITIONAL 시 전체 output contract 포함

Level 3 — 심층 분석 (명시적 요청 시)

• modules/ 파일 로드 (fda-criteria.md, eu-mdr-criteria.md, mfds-criteria.md)
• 4-Gate 분석 (MFDS 디지털)
• Combination Product Detection
• Annex XVI Detection

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

CONDITIONAL Output Contract

When determination is CONDITIONAL for any jurisdiction, the following fields are MANDATORY:

Field	Description	Example
Uncertainty Basis	Specific regulatory boundary being straddled	"FDA General Wellness Policy boundary: respiratory monitoring features may exceed wellness scope"
Resolution Conditions	What information or decision would resolve to YES or NO	"Intended use claims limited to wellness → NO; Any diagnostic/screening claim → YES"
If YES Scenario	Likely regulatory next step assuming device status	"Proceed with device-specific regulatory assessment"
If NO Scenario	Regulatory status assuming non-device	"Not subject to medical-device regulation on the current facts"

CONDITIONAL triggers (non-exhaustive):

1. Wellness/medical device boundary (FDA General Wellness Policy, MFDS 건강지원제품)
2. Borderline products (EU MDR MDCG 2019-11)
3. Combination products (drug-device, biologic-device) — see Combination Product Detection below
4. Software boundary (CDS exemption, general purpose computing)
5. Intended use ambiguity (claims could be interpreted either way)

CRITICAL: Do NOT collapse CONDITIONAL to YES or NO. If uncertainty exists, output CONDITIONAL with all mandatory fields. Each jurisdiction is evaluated independently — one jurisdiction may be YES while another is CONDITIONAL.

Knowledge Base Date: 2026-01

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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

MFDS 4-Gate Analysis (Mandatory for Digital Products)

When the product involves digital technology (SW, AI, IoT, VR/AR, intelligent robot, HPC), the 4-Gate analysis from modules/mfds-criteria.md Section "4-Gate Decision Logic" MUST be executed during determination and its result shown in the output.

Execute each gate and output the result explicitly:

1. Gate 1: 의료기기 해당 여부 (Step 1 결과 반영)
2. Gate 2: 디지털 기술 적용 여부 (SW, AI, IoT, VR/AR 등)
3. Gate 3: 핵심 기능 영향 여부
4. Gate 4: 배제 원칙 확인

MANDATORY OUTPUT FORMAT (Level 2+ only, when digital technology is involved):

### MFDS 4-Gate Analysis
- Gate 1 (의료기기 해당): [PASS/FAIL] — [근거]
- Gate 2 (디지털 기술): [PASS/EXIT] — [기술 유형 또는 "비디지털 기기"]
- Gate 3 (핵심 기능 영향): [PASS/FAIL] — [영향 분석] (Gate 2 EXIT 시 N/A)
- Gate 4 (배제 원칙): [PASS/EXIT] — [배제 해당 여부] (Gate 2 EXIT 시 N/A)
- **Result**: [디지털의료기기 해당 / Gate 2 EXIT (비디지털) / 비해당]

• 4-Gate 통과 (디지털의료기기): Include in determination output and explain the digital-device significance
• Gate 2 EXIT (비디지털): State explicitly — device is medical device but not digital medical device
• Gate 1 FAIL: Device is not a medical device → determination NO

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Analysis Workflow

Step 0 (pre-analysis)

Level 1 (기본): 외부 reference 로드 없이 위 Decision Framework와 현재 스킬 본문만으로 판단.
Level 2: 가장 관련성 높은 jurisdiction의 modules/ 파일만 로드해 판단을 보강.
Level 3: 관련 modules/를 조합해 다지역 비교와 심화 판단을 수행.

Current v1.0 source of truth:

• this SKILL.md
• modules/fda-criteria.md
• modules/eu-mdr-criteria.md
• modules/mfds-criteria.md
• modules/combination-detection.md
• modules/annex-xvi-detection.md

Removed global knowledge trees are not part of the shipped v1.0 surface.
If a precise citation cannot be supported from the bundled skill logic, say that regulatory database verification is required.

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 conclusions
• return an insufficiency rationale

Interactive mode (conversational context):

• ask 1-3 minimum follow-up questions that directly resolve missing inputs

Batch/JSON-output mode (when prompt requests strict JSON output):

• do NOT add extra keys to the JSON (e.g., insufficient, missing_fields are FORBIDDEN)
• express insufficiency only through the keys already defined by the caller's schema
• keep the output schema-valid and determination-focused

Step 2: Apply Multi-Region Criteria

For each target region (FDA, EU MDR, MFDS):

1. (Level 2+) Load the region-specific module (modules/fda-criteria.md, modules/eu-mdr-criteria.md, modules/mfds-criteria.md). Level 1에서는 위 Decision Framework만 사용.
2. Execute the module's decision tree
3. At each decision point, evaluate whether the answer is clear (YES/NO) or uncertain (CONDITIONAL)
4. CONDITIONAL gate: If any of the following are true, the determination MUST be CONDITIONAL:
   • The product straddles a wellness/medical boundary
   • The intended use could be interpreted as either medical or non-medical
   • The product is a combination product (drug-device, biologic-device)
   • Regulatory guidance explicitly identifies the product type as borderline
   • The product fits a new regulatory category (e.g., MFDS 건강지원제품) that is distinct from both "device" and "non-device"
5. When CONDITIONAL: populate all CONDITIONAL output contract fields (see above)

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

Evidence Requirements (per jurisdiction)

Each determination MUST include specific regulatory citations:

• FDA: 21 CFR section (e.g., 21 CFR 201(h)), relevant guidance document(s) (e.g., FDA General Wellness Policy), predicate device (if applicable)
• EU MDR: Article reference (e.g., Article 2(1)), applicable MDCG guidance (e.g., MDCG 2019-11 for borderline products)
• MFDS: 의료기기법 조항 (e.g., 제2조 정의), 품목코드 (Axxxxx.xx if known), 관련 고시/가이드라인 (e.g., 디지털의료제품법 제3조)

CRITICAL: Do NOT fabricate regulatory citations. If a specific citation is uncertain, state "requires regulatory database verification."

MANDATORY OUTPUT FORMAT (Level 2+ only):

### Regulatory Evidence
- **FDA Legal Basis**: 21 CFR [section] (e.g., 21 CFR 201(h)) — Guidance: [document name if applicable]
- **EU MDR Legal Basis**: [Article reference] (e.g., Article 2(1)) — MDCG: [guidance number if applicable]
- **MFDS Legal Basis**: [법률 조항] (e.g., 「의료기기법」 제2조) — 고시/가이드라인: [명칭 if applicable]
- **Citations**:
  - [FDA] 21 CFR § [specific section]
  - [EU MDR] Article/Annex [reference]
  - [MFDS] [법률/고시 reference]

MANDATORY OUTPUT FORMAT (Level 2+ only):

### Confidence & Escalation
- **Confidence Score**: [0-100]% — [basis: e.g., "clear medical purpose, well-established device category"]
- **Escalation Level**: [1-4]
  - 1 = Automated processing sufficient
  - 2 = Brief expert review recommended
  - 3 = Expert review required (borderline/CONDITIONAL)
  - 4 = Regulatory authority consultation required
- **Next Action**: [recommended next step]

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Combination Product Detection (P5)

Combination product (drug-device, biologic-device) 감지 시 → CONDITIONAL 판정.

Detail: See modules/combination-detection.md

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Annex XVI Detection (Non-Medical Purpose Devices)

Non-medical purpose device (Annex XVI) 감지 시 → SPECIAL/IN SCOPE 판정.

Detail: See modules/annex-xvi-detection.md

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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.