claude-code-arcane 1.0.0

package/skills/mdr-745-specialist/SKILL.md

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+---
+name: mdr-745-specialist
+description: "EU MDR 2017/745 compliance — device classification, technical documentation, clinical evidence, post-market surveillance, and EUDAMED."
+argument-hint: ""
+category: "regulatory"
+user-invocable: true
+allowed-tools: Read, Glob, Grep, Bash
+---
+# MDR 2017/745 Specialist
+
+EU MDR compliance patterns for medical device classification, technical documentation, and clinical evidence.
+
+## Device Classification (Annex VIII)
+
+1. Identify duration (transient, short-term, long-term)
+2. Determine invasiveness (non-invasive, body orifice, surgical)
+3. Assess body system contact (CNS, cardiac, other)
+4. Check if active device (energy dependent)
+5. Apply classification rules 1-22; for software, apply MDCG 2019-11
+6. Document classification rationale
+7. **Validation:** Classification confirmed with Notified Body
+
+### Classification Matrix
+
+| Factor | Class I | Class IIa | Class IIb | Class III |
+|--------|---------|-----------|-----------|-----------|
+| Duration | Any | Short-term | Long-term | Long-term |
+| Invasiveness | Non-invasive | Body orifice | Surgical | Implantable |
+| System | Any | Non-critical | Critical organs | CNS/cardiac |
+
+For complete Annex VIII rules, software classification (MDCG 2019-11), and worked examples, see [references/mdr-classification-guide.md](references/mdr-classification-guide.md).
+
+---
+
+## Technical Documentation (Annex II/III)
+
+1. Create device description (variants, accessories, intended purpose)
+2. Develop labeling (Article 13, IFU)
+3. Document design and manufacturing process
+4. Complete GSPR compliance matrix
+5. Prepare benefit-risk analysis
+6. Compile V&V evidence, integrate risk management file (ISO 14971)
+7. **Validation:** Technical file reviewed for completeness
+
+### Conformity Assessment Routes
+
+| Class | Route | NB Involvement |
+|-------|-------|----------------|
+| I | Annex II self-declaration | None |
+| IIa | Annex II + IX or XI | Product or QMS |
+| IIb | Annex IX + X or X + XI | Type exam + production |
+| III | Annex IX + X | Full QMS + type exam |
+
+For GSPR checklist template, technical file structure, and DoC template, see [references/technical-documentation-templates.md](references/technical-documentation-templates.md).
+
+---
+
+## Clinical Evidence (Annex XIV)
+
+1. Define clinical claims and endpoints
+2. Conduct systematic literature search
+3. Appraise data quality, assess equivalence
+4. Identify evidence gaps, determine if investigation required
+5. Prepare Clinical Evaluation Report (CER)
+6. **Validation:** CER reviewed by qualified evaluator
+
+| Class | Minimum Evidence | Investigation |
+|-------|------------------|---------------|
+| I | Risk-benefit analysis | Not typically required |
+| IIa | Literature + post-market | May be required |
+| IIb | Systematic literature review | Often required |
+| III | Comprehensive clinical data | Required (Article 61) |
+
+For CER structure, qualified evaluator requirements, and PMCF guidance, see [references/clinical-evidence-requirements.md](references/clinical-evidence-requirements.md).
+
+---
+
+## Post-Market Surveillance
+
+| Component | Requirement | Frequency |
+|-----------|-------------|-----------|
+| PMS Plan | Article 84 | Maintain current |
+| PSUR | Class IIa+ | Per class schedule |
+| PMCF Plan | Annex XIV Part B | Update with CER |
+| Vigilance | Articles 87-92 | As events occur |
+
+Serious incident reporting: 2 days (public health threat), 10 days (death/serious), 15 days (other).
+
+---
+
+## EUDAMED and UDI
+
+1. Obtain issuing entity code (GS1, HIBCC, ICCBBA)
+2. Assign UDI-DI/UDI-PI, apply carriers to labels
+3. Register in EUDAMED (actor, devices, certificates)
+4. **Validation:** UDI verified on sample labels
+
+---
+
+## Tools and References
+
+```bash
+python scripts/mdr_gap_analyzer.py --device "Device Name" --class IIa
+```
+
+| Document | Content |
+|----------|---------|
+| [mdr-classification-guide.md](references/mdr-classification-guide.md) | Annex VIII rules, software classification, examples |
+| [clinical-evidence-requirements.md](references/clinical-evidence-requirements.md) | CER structure, PMCF guidance |
+| [technical-documentation-templates.md](references/technical-documentation-templates.md) | Annex II/III content, GSPR matrix, DoC |

package/skills/mdr-745-specialist/references/clinical-evidence-requirements.md

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+# Clinical Evidence Requirements
+
+MDR Annex XIV clinical evaluation and post-market clinical follow-up guidance.
+
+---
+
+## Table of Contents
+
+- [Clinical Evidence Framework](#clinical-evidence-framework)
+- [Clinical Evaluation Process](#clinical-evaluation-process)
+- [Literature-Based Evidence](#literature-based-evidence)
+- [Clinical Investigation Requirements](#clinical-investigation-requirements)
+- [Post-Market Clinical Follow-up](#post-market-clinical-follow-up)
+
+---
+
+## Clinical Evidence Framework
+
+### Evidence Hierarchy
+
+| Evidence Type | Strength | When to Use |
+|---------------|----------|-------------|
+| Randomized Controlled Trial | Highest | Novel Class III, high-risk claims |
+| Prospective cohort study | High | New technology, performance claims |
+| Retrospective analysis | Medium | Established technology, equivalence |
+| Literature review | Medium | Well-characterized, equivalent devices |
+| Expert opinion | Low | Supportive only, not primary |
+
+### Evidence Requirements by Class
+
+| Class | Minimum Evidence | Clinical Investigation |
+|-------|------------------|------------------------|
+| I | Risk-benefit analysis | Not typically required |
+| IIa | Literature + post-market data | May be required for novel tech |
+| IIb | Systematic literature review | Often required for claims |
+| III | Comprehensive clinical data | Required unless equivalent |
+
+### Clinical Evidence Pathway
+
+Determine evidence strategy:
+
+1. Assess device classification and risk level
+2. Evaluate claim significance (diagnostic, therapeutic)
+3. Determine if equivalence can be demonstrated
+4. Identify available literature and clinical data
+5. Assess gaps requiring additional investigation
+6. Develop PMCF plan for ongoing evidence
+7. **Validation:** Evidence strategy approved by Notified Body
+
+---
+
+## Clinical Evaluation Process
+
+### Clinical Evaluation Workflow
+
+Execute clinical evaluation per Annex XIV Part A:
+
+1. Identify relevant safety and performance data
+2. Define scope and search strategy
+3. Conduct systematic literature search
+4. Appraise and analyze clinical data
+5. Assess benefit-risk profile
+6. Document conclusions in Clinical Evaluation Report (CER)
+7. Plan post-market clinical follow-up
+8. **Validation:** CER reviewed by qualified clinical evaluator
+
+### Clinical Evaluation Report Structure
+
+```
+CLINICAL EVALUATION REPORT (CER)
+├── 1. Executive Summary
+│   ├── Device description and intended purpose
+│   ├── Conclusions on safety and performance
+│   └── Benefit-risk conclusion
+├── 2. Scope of Clinical Evaluation
+│   ├── Device identification
+│   ├── Clinical claims to be evaluated
+│   └── Equivalence assessment (if applicable)
+├── 3. Clinical Background
+│   ├── Disease/condition overview
+│   ├── Current treatment options
+│   └── State of the art
+├── 4. Clinical Data Sources
+│   ├── Pre-clinical data (bench, animal)
+│   ├── Clinical investigation data
+│   ├── Literature search methodology
+│   └── Post-market surveillance data
+├── 5. Data Appraisal
+│   ├── Study quality assessment
+│   ├── Relevance to subject device
+│   └── Data contribution to evaluation
+├── 6. Data Analysis
+│   ├── Safety analysis
+│   ├── Performance analysis
+│   └── Benefit-risk determination
+├── 7. Conclusions
+│   ├── Clinical evidence summary
+│   ├── Residual risks
+│   └── PMCF requirements
+└── 8. PMCF Plan Summary
+    ├── Data gaps identified
+    ├── PMCF activities planned
+    └── Update schedule
+```
+
+### Qualified Clinical Evaluator
+
+Requirements per Annex XIV:
+
+- Medical degree or equivalent healthcare qualification
+- 4+ years clinical experience in relevant field OR
+- Research background in relevant domain
+- Training in clinical evaluation methodology
+- Understanding of MDR requirements
+
+---
+
+## Literature-Based Evidence
+
+### Literature Search Strategy
+
+Execute systematic literature review:
+
+1. Define PICO question (Population, Intervention, Comparison, Outcome)
+2. Develop search string with Boolean operators
+3. Select databases (PubMed, Embase, Cochrane, etc.)
+4. Set date range and language filters
+5. Execute search and document results
+6. Screen abstracts and full texts
+7. **Validation:** Reproducible search, documented exclusion criteria
+
+### Database Selection
+
+| Database | Coverage | Best For |
+|----------|----------|----------|
+| PubMed/MEDLINE | Biomedical literature | Primary clinical data |
+| Embase | Drugs, devices, biomedical | European studies |
+| Cochrane Library | Systematic reviews | Meta-analyses |
+| CINAHL | Nursing, allied health | User studies |
+| IEEE Xplore | Engineering | Technical performance |
+| Manufacturer data | Proprietary | Direct device data |
+
+### Data Appraisal Criteria
+
+Evaluate each source:
+
+| Criterion | Assessment | Score |
+|-----------|------------|-------|
+| Study design | RCT > cohort > case series | 1-5 |
+| Sample size | Statistical power adequate | 1-5 |
+| Follow-up duration | Sufficient for outcomes | 1-5 |
+| Population relevance | Matches IFU population | 1-5 |
+| Device equivalence | Technical, biological, clinical | 1-5 |
+| Bias risk | Low/medium/high | 1-5 |
+
+### Equivalence Assessment
+
+Demonstrate equivalence per MDCG 2020-5:
+
+**Technical equivalence:**
+- Similar design
+- Same materials
+- Same specifications
+- Same manufacturing process
+
+**Biological equivalence:**
+- Same tissue contact
+- Same biocompatibility
+- Same sterilization method
+
+**Clinical equivalence:**
+- Same intended purpose
+- Same clinical condition
+- Same patient population
+- Same user (professional/lay)
+
+---
+
+## Clinical Investigation Requirements
+
+### When Investigation is Required
+
+Clinical investigation mandatory:
+
+- [ ] Class III implantable devices (Article 61(4))
+- [ ] Novel technology without equivalent
+- [ ] Significant modification to existing device
+- [ ] New clinical claims not supported by literature
+- [ ] Addressing gaps identified in clinical evaluation
+
+### Clinical Investigation Workflow
+
+Conduct clinical investigation:
+
+1. Develop Clinical Investigation Plan (CIP)
+2. Submit to Ethics Committee for approval
+3. Notify Competent Authority (via EUDAMED)
+4. Conduct investigation per GCP principles
+5. Collect and analyze clinical data
+6. Prepare Clinical Investigation Report
+7. Submit serious adverse event reports (within 7-15 days)
+8. **Validation:** All subjects completed, data lock achieved
+
+### Clinical Investigation Plan Elements
+
+| Section | Content |
+|---------|---------|
+| Objectives | Primary and secondary endpoints |
+| Design | Randomized, controlled, blinded |
+| Population | Inclusion/exclusion criteria |
+| Sample size | Statistical justification |
+| Procedures | Visit schedule, assessments |
+| Endpoints | Safety and performance measures |
+| Analysis | Statistical methods |
+| Safety | Adverse event definitions, reporting |
+
+### Ethics Committee Submission
+
+Required documentation:
+
+- Clinical Investigation Plan
+- Investigator's Brochure
+- Informed consent documents
+- Case Report Forms
+- Investigator CVs
+- Insurance certificate
+- Device documentation
+
+---
+
+## Post-Market Clinical Follow-up
+
+### PMCF Plan Requirements
+
+Develop PMCF Plan per Annex XIV Part B:
+
+1. Identify residual risks from clinical evaluation
+2. Define clinical questions to address
+3. Select PMCF methods (survey, registry, study)
+4. Specify endpoints and success criteria
+5. Define timeline and milestones
+6. Plan data collection and analysis
+7. Schedule PMCF Evaluation Report updates
+8. **Validation:** PMCF Plan approved by Notified Body
+
+### PMCF Methods
+
+| Method | Description | Best For |
+|--------|-------------|----------|
+| Literature review | Ongoing systematic search | Mature devices |
+| Survey | User/patient questionnaire | Real-world experience |
+| Registry | Multi-site data collection | Long-term outcomes |
+| PMCF study | Prospective clinical study | Specific questions |
+| Complaint analysis | Structured complaint review | Safety signals |
+| Vigilance data | MAUDE, EUDAMED analysis | Comparative safety |
+
+### PMCF Evaluation Report
+
+Update frequency:
+
+| Device Class | Update Frequency |
+|--------------|------------------|
+| Class III | Annual |
+| Class IIb implantable | Annual |
+| Class IIb | Every 2 years |
+| Class IIa | Every 2-5 years |
+| Class I | When clinically relevant |
+
+### PMCF Report Structure
+
+```
+PMCF EVALUATION REPORT
+├── 1. Executive Summary
+│   └── Key findings and conclusions
+├── 2. Scope
+│   ├── Device covered
+│   └── Reporting period
+├── 3. PMCF Activities
+│   ├── Methods employed
+│   └── Data sources
+├── 4. Results
+│   ├── Safety data
+│   ├── Performance data
+│   └── Clinical questions addressed
+├── 5. Conclusions
+│   ├── Benefit-risk confirmation
+│   ├── Residual risks updated
+│   └── Need for corrective action
+└── 6. Next Steps
+    ├── CER update requirements
+    └── PMCF Plan modifications
+```
+
+### Integration with CER
+
+PMCF data feeds clinical evaluation:
+
+1. PMCF data collected per plan
+2. Data analyzed in PMCF Evaluation Report
+3. CER updated with PMCF conclusions
+4. Risk management file updated
+5. IFU updated if needed
+6. **Validation:** CER update cycle completed

package/skills/mdr-745-specialist/references/mdr-classification-guide.md

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+# MDR Device Classification Guide
+
+EU MDR 2017/745 Annex VIII classification rules and decision framework.
+
+---
+
+## Table of Contents
+
+- [Classification Overview](#classification-overview)
+- [Classification Rules](#classification-rules)
+- [Software Classification (MDCG 2019-11)](#software-classification)
+- [Classification Examples](#classification-examples)
+- [Conformity Assessment Routes](#conformity-assessment-routes)
+
+---
+
+## Classification Overview
+
+### Risk Class Hierarchy
+
+| Class | Risk Level | Examples | NB Required |
+|-------|------------|----------|-------------|
+| I | Lowest | Bandages, wheelchairs, stethoscopes | No (self-certification) |
+| IIa | Low-Medium | Hearing aids, dental filling materials | Yes |
+| IIb | Medium-High | Ventilators, blood bags, implantable sutures | Yes |
+| III | Highest | Pacemakers, heart valves, hip implants | Yes |
+
+### Classification Factors
+
+Determine class based on:
+
+1. **Duration of contact:**
+   - Transient: < 60 minutes
+   - Short-term: 60 min to 30 days
+   - Long-term: > 30 days
+
+2. **Degree of invasiveness:**
+   - Non-invasive
+   - Invasive via body orifice
+   - Surgically invasive
+   - Implantable
+
+3. **Body system interaction:**
+   - Central circulatory system
+   - Central nervous system
+   - Other organ systems
+
+4. **Active vs. passive:**
+   - Active devices (energy dependent)
+   - Passive devices
+
+---
+
+## Classification Rules
+
+### Non-Invasive Devices (Rules 1-4)
+
+**Rule 1 - General non-invasive:**
+- Class I (unless covered by other rules)
+- Example: Wheelchairs, hospital beds, collection devices
+
+**Rule 2 - Channeling or storing:**
+- Class IIa: Blood bags, transfusion sets (>60 min contact)
+- Class IIb: Blood storage, organ storage
+- Class I: Simple channeling (gravity, IV bag without additives)
+
+**Rule 3 - Modifying biological composition:**
+- Class IIa: Filters, gas separators, dialysis filters
+- Class IIb: Blood filtration, exchange transfusion
+
+**Rule 4 - Contact with injured skin:**
+- Class I: Wound dressings for superficial wounds
+- Class IIa: Wounds in dermis requiring secondary intent healing
+- Class IIb: Severe wounds, chronic wounds, burns
+
+### Invasive Devices (Rules 5-8)
+
+**Rule 5 - Body orifice invasive (transient):**
+- Class I: Transient use, non-surgically invasive
+- Class IIa: Short-term use
+- Class IIb: Long-term use in oral cavity
+
+**Rule 6 - Surgically invasive (transient):**
+- Class IIa: Transient use
+- Exception Class I: Reusable surgical instruments
+
+**Rule 7 - Surgically invasive (short-term):**
+- Class IIa: Short-term (< 30 days)
+- Class IIb: Central circulatory or CNS contact
+- Class III: Chemical change or drug delivery
+
+**Rule 8 - Implantable and long-term surgically invasive:**
+- Class IIb: General implants
+- Class III: Heart, CNS, spine contact; drug delivery; biological origin
+
+### Active Devices (Rules 9-13)
+
+**Rule 9 - Active therapeutic devices:**
+- Class IIa: Exchange or admin of energy (non-hazardous)
+- Class IIb: Potentially hazardous energy levels
+
+**Rule 10 - Active diagnostic devices:**
+- Class IIa: Supply energy for imaging, monitoring
+- Class IIb: Monitor vital physiological parameters
+
+**Rule 11 - Software:**
+- Class IIa: Information for diagnostic/therapeutic decisions (non-serious)
+- Class IIb: Decisions that could cause death/irreversible deterioration
+- Class III: Decisions with immediate risk to life
+- See MDCG 2019-11 for detailed algorithm
+
+**Rule 12 - Active devices administering substances:**
+- Class IIa: Non-hazardous manner
+- Class IIb: Potentially hazardous manner
+
+**Rule 13 - Other active devices:**
+- Class I: All other active devices
+
+### Special Rules (Rules 14-22)
+
+**Rule 14 - Contraception/STI prevention:**
+- Class IIb: Contraceptive devices
+- Class III: Implantable contraceptives
+
+**Rule 15 - Disinfection/sterilization:**
+- Class IIa: Disinfection of devices
+- Class IIb: Disinfection of invasive devices
+
+**Rule 16 - X-ray diagnostic recording:**
+- Class IIa: Recording media for x-ray
+
+**Rule 17 - Devices with nanomaterials:**
+- Class III: High internal exposure potential
+- Class IIb: Medium exposure
+- Class IIa: Low exposure
+
+**Rule 18 - Blood/plasma derivatives:**
+- Class III: Utilizing blood derivatives
+
+**Rule 19 - Drug delivery systems:**
+- Class III: Integral drug administration
+
+**Rule 20 - Breath analyzers for anesthesia:**
+- Class IIb: Breath analyzers
+
+**Rule 21 - Medicinal substance devices:**
+- Class III: Incorporating medicinal substances
+
+**Rule 22 - Closed-loop therapeutic systems:**
+- Class III: Closed-loop systems
+
+---
+
+## Software Classification
+
+### MDCG 2019-11 Decision Algorithm
+
+Execute software classification:
+
+1. Determine if software qualifies as medical device
+2. Identify significance of information to healthcare decision
+3. Assess healthcare situation or patient condition
+4. Apply rule 11 based on severity
+5. **Validation:** Classification rationale documented with MDCG reference
+
+### Software Classification Matrix
+
+| Information Significance | Situation/Condition | Class |
+|--------------------------|---------------------|-------|
+| Informs clinical management | Non-serious | IIa |
+| Informs clinical management | Serious | IIb |
+| Informs clinical management | Critical | III |
+| Drives clinical management | Non-serious | IIa |
+| Drives clinical management | Serious | IIb |
+| Drives clinical management | Critical | III |
+| Treats or diagnoses | Non-serious | IIa |
+| Treats or diagnoses | Serious | IIb |
+| Treats or diagnoses | Critical | III |
+
+### Software Examples
+
+| Software Type | Class | Rationale |
+|---------------|-------|-----------|
+| Patient record viewing | Not MD | Administrative, not clinical |
+| Medication reminder app | Class I | General wellness |
+| Blood glucose monitor app | Class IIa | Informs non-serious decisions |
+| Sepsis detection algorithm | Class IIb | Informs serious condition |
+| AI tumor detection | Class III | Diagnoses critical condition |
+| Closed-loop insulin delivery | Class III | Treats critical condition |
+
+---
+
+## Classification Examples
+
+### Example 1: Surgical Suture (Absorbable)
+
+```
+Device: Absorbable suture for internal wound closure
+Analysis:
+- Invasiveness: Surgically invasive
+- Duration: Long-term (absorbed over > 30 days)
+- System: General tissue (not CNS, not cardiac)
+- Rule Applied: Rule 8 (implantable, long-term)
+
+Classification: Class IIb
+Rationale: Implantable device > 30 days, general tissue
+Conformity Route: Annex IX (Type examination) + Annex XI
+```
+
+### Example 2: Blood Pressure Monitor
+
+```
+Device: Home blood pressure monitoring device
+Analysis:
+- Active: Yes (electronic measurement)
+- Function: Monitoring vital physiological parameter
+- Risk: Non-immediate (home use, not ICU)
+- Rule Applied: Rule 10 (active diagnostic)
+
+Classification: Class IIa
+Rationale: Monitors vital parameter, non-critical setting
+Conformity Route: Annex IX or XI (QMS + product verification)
+```
+
+### Example 3: Hip Implant
+
+```
+Device: Total hip replacement prosthesis
+Analysis:
+- Invasiveness: Surgically invasive, implantable
+- Duration: Long-term (permanent)
+- System: Musculoskeletal
+- Rule Applied: Rule 8 (implantable, long-term)
+
+Classification: Class III
+Rationale: Implantable > 30 days in direct contact with bone
+Conformity Route: Annex IX + Annex X (full QMS + type examination)
+```
+
+### Example 4: Diagnostic Software (AI)
+
+```
+Device: AI-based chest X-ray analysis for pneumonia detection
+Analysis:
+- Software: Qualifies as medical device (clinical decision)
+- Information: Diagnoses condition
+- Condition: Serious (pneumonia can be life-threatening)
+- Rule Applied: Rule 11 + MDCG 2019-11
+
+Classification: Class IIb
+Rationale: Software diagnosing serious condition
+Conformity Route: Annex IX or Annex XI
+```
+
+---
+
+## Conformity Assessment Routes
+
+### By Device Class
+
+| Class | Conformity Route | NB Involvement |
+|-------|------------------|----------------|
+| I | Annex II (self-declaration) | None |
+| I (sterile/measuring) | Annex II + IX/XI | Sterile/measuring aspects |
+| IIa | Annex II + IX or XI | Product verification or QMS |
+| IIb | Annex IX + X or Annex X + XI | Type exam + QMS or production |
+| III | Annex IX + X | Full QMS + type examination |
+
+### Annex Reference
+
+| Annex | Content | Purpose |
+|-------|---------|---------|
+| II | Technical documentation | Required for all classes |
+| III | Technical documentation (additions) | Class III additions |
+| IX | Conformity assessment (QMS) | Quality management route |
+| X | Type examination | Product design examination |
+| XI | Product verification | Production quality checks |
+
+### Decision Workflow
+
+Select conformity route:
+
+1. Determine device classification (Rules 1-22)
+2. Identify applicable annexes for class
+3. Evaluate QMS maturity (Annex IX capability)
+4. Consider production volume (batch vs. mass)
+5. Assess Notified Body capacity and timeline
+6. Select optimal conformity assessment route
+7. **Validation:** Route confirmed with Notified Body consultation