Medical Device Classification Skill
Purpose
Determine regulatory class across FDA, EU MDR, and MFDS jurisdictions. This is a pure analysis unit that receives device characteristics and returns a structured classification result.
Input: Device characteristics (invasiveness, duration, active/passive, body system, anatomical location) Output: Multi-region classification matrix, rationale, traffic light per region Knowledge Base Date: 2026-01
Multi-Region Classification Matrix:
| Region | Classes | Risk Levels |
|---|---|---|
| FDA | I, II, III | Low, Moderate, High |
| EU MDR | I, IIa, IIb, III | Low, Medium-Low, Medium-High, High |
| MFDS | 1, 2, 3, 4 | Low, Low-Medium, Medium-High, High |
Key Classification Factors:
- •Invasiveness (non-invasive, invasive, implantable)
- •Duration of contact (transient, short-term, long-term)
- •Active vs passive device
- •Intended use and body system interaction
- •Anatomical location
Decision Framework
FDA Classification Logic
Class I (Low Risk)
- •Minimal potential for harm
- •Simple design and functionality
- •Examples: Manual surgical instruments, tongue depressors, arm slings
Decision Factors:
- •Non-invasive or minimally invasive
- •Short contact duration
- •Passive device
- •Well-established technology
Class II (Moderate Risk)
- •Moderate potential for harm if controls insufficient
- •Requires special controls (performance standards, post-market surveillance)
- •Examples: Powered wheelchairs, infusion pumps, surgical drapes
Decision Factors:
- •Invasive or sustained contact
- •Active device with power source
- •Requires performance validation
- •More complex than Class I but not life-sustaining
Class III (High Risk)
- •High risk of illness or injury
- •Usually supports or sustains human life
- •Implanted devices or long-term contact
- •Examples: Heart valves, pacemakers, breast implants
Decision Factors:
- •Implantable
- •Life-sustaining or life-supporting
- •Long-term body contact
- •High risk to health if failure occurs
EU MDR Annex VIII Classification Logic
Class I (Low Risk)
- •Non-invasive devices
- •Transient use (<60 minutes)
- •Minimal risk profile
Class IIa (Medium-Low Risk)
- •Short-term invasive devices (<=30 days)
- •Transient use with specific body systems
- •Examples: Contact lenses, hearing aids
Decision Rules:
- •Rule 5: Non-invasive devices channeling/storing body substances - IIa
- •Rule 6: Short-term invasive surgically devices - IIa
Class IIb (Medium-High Risk)
- •Long-term invasive devices (>30 days)
- •Active therapeutic devices
- •Examples: Lung ventilators, bone screws
Decision Rules:
- •Rule 8: Long-term implantable devices (except teeth/Rule 8 exceptions) - IIb
- •Rule 11: Active therapeutic devices for energy delivery - IIb
Class III (High Risk)
- •Devices in direct contact with heart, central circulatory system, CNS
- •Implantable/long-term devices affecting vital functions
- •Examples: Heart valves, drug-eluting stents
Decision Rules:
- •Rule 9: Active therapeutic devices for life-support/vital functions - III
- •Rule 10: Devices with biological substances - III
MFDS Classification Criteria
Class 1
- •Minimal potential harm
- •Examples: Medical scissors, tweezers, tongue depressors
Class 2
- •Low to moderate potential harm or simple usage
- •Examples: MRI, ultrasound imaging, powered wheelchair
Classification criteria:
- •Non-invasive or minimally invasive
- •Transient contact
- •Low risk of harm on failure
Class 3
- •Moderate to high potential harm or relatively complex usage
- •Examples: Ventilators, dialysis machines, contact lenses
Classification criteria:
- •Invasive use
- •Medium or long-term contact
- •Active medical device
Class 4
- •High potential harm or significant risk to life on malfunction
- •Examples: Pacemakers, artificial heart valves, stents
Classification criteria:
- •Implantable medical device
- •Life-sustaining device
- •Direct contact with CNS or cardiovascular system
Analysis Workflow
Step 1: Extract Device Characteristics
- •Device type and intended use
- •Invasiveness level (non-invasive, invasive, implantable)
- •Duration of contact (transient <60min, short-term <=30 days, long-term >30 days)
- •Active vs passive classification
- •Body system interaction
- •Anatomical location
Step 2: Apply FDA Classification Rules
- •Assess device type and intended use
- •Determine if predicate device exists (510(k) pathway)
- •Evaluate risk factors (invasiveness, duration, active/passive)
- •Check for life-supporting/life-sustaining characteristics
- •Assign FDA Class (I, II, or III)
Step 3: Apply EU MDR Annex VIII Rules
- •Apply classification rules 1-22 in sequence
- •Evaluate invasiveness and duration
- •Check for special rules (implantable, CNS, cardiovascular)
- •Resolve conflicts (higher class takes precedence)
- •Assign EU MDR Class (I, IIa, IIb, or III)
Step 4: Apply MFDS Classification Criteria
- •Assess potential harm level
- •Evaluate complexity of use
- •Check for implantable or life-sustaining characteristics
- •Consider Korean regulatory nuances
- •Assign MFDS Class (1, 2, 3, or 4)
Step 5: Generate Classification Matrix
- •Consolidate multi-region classifications
- •Identify classification rationale per region
- •Reference applicable rules and regulations
- •Flag any discrepancies between regions
Step 6: (Optional) Classification Optimization Analysis
Analyze key decision factors for potential class reduction:
- •Invasiveness: Can design reduce invasiveness level?
- •Duration: Can contact duration be shortened?
- •Active/Passive: Can device be made passive?
- •Body System: Can device avoid high-risk anatomical locations?
Optimization output constraints:
- •Abstract guidance only, NOT specific design recommendations
- •Mandatory YELLOW traffic light
- •Mandatory escalation to R&D + Regulatory affairs collaboration
- •No guarantees of class reduction approval
Traffic Light Criteria
GREEN: Clear Classification
- •All three regions have definitive class assignments
- •Classification rules clearly applicable
- •No borderline characteristics
- •Standard regulatory pathway identified
YELLOW: Conditional / Requires Attention
- •One or more regions have borderline classification
- •Classification optimization analysis requested
- •Cross-region discrepancies exist
- •Novel device type without clear precedent
- •Mandatory escalation to human expert
RED: Classification Blocked
- •Unable to classify due to insufficient device information
- •Conflicting classification rules with no resolution
- •Device type outside known classification framework
Escalation Path
Ambiguous Classification Scenarios (YELLOW Traffic Light)
Cross-Region Discrepancies:
- •Different classes assigned across FDA, EU MDR, MFDS
- •Action: Regulatory strategy consultation to align global approach
Borderline Between Classes:
- •Device characteristics straddle two classes
- •Action: Regulatory specialist review + agency pre-submission meeting
Novel Device Types (Mandatory Escalation)
No Clear Precedent:
- •New technology without established classification pathway
- •Action: De Novo pathway (FDA) or Innovation Office consultation (EU MDR)
High-Risk Scenarios
- •Class III FDA or EU MDR Class III
- •Class 4 MFDS
- •Implantable or life-sustaining devices
- •Always requires comprehensive regulatory strategy
Classification Optimization Logic
Purpose: Analyze key decision factors to identify potential pathways for class reduction through design modifications.
1. Invasiveness Factor
Optimization Guidance:
- •If implantable: Consider alternative non-implantable designs
- •If invasive: Evaluate minimally invasive or non-invasive approaches
- •If non-invasive: Already optimal for this factor
2. Duration Factor
Optimization Guidance:
- •If long-term: Explore short-term or transient use designs
- •If short-term: Consider transient use if clinically feasible
- •If transient: Already optimal for this factor
3. Active vs Passive Factor
Optimization Guidance:
- •If active: Assess feasibility of passive design alternatives
- •If passive: Already optimal for this factor
4. Anatomical Location Factor
Optimization Guidance:
- •If CNS/cardiovascular: Explore designs avoiding direct contact with these systems
- •If other high-risk locations: Consider alternative placement
- •If low-risk location: Already optimal for this factor
Optimization Disclaimer
Classification optimization analysis requires:
- •R&D feasibility assessment
- •Clinical performance validation
- •Regulatory strategy alignment
- •Potential additional clinical data requirements
Data Source Strategy
- •Built-in Knowledge (Primary): Embedded classification rules from FDA, EU MDR Annex VIII, MFDS regulations
- •Module Files (On-demand): Detailed classification rules and decision trees (future)
- •MCP Connectors (Supplementary): Organization-specific classification precedents and verification
For MCP integration patterns (tool discovery, graceful degradation, source attribution), see CONNECTORS.md.