diff --git a/.codex/skills-index.json b/.codex/skills-index.json index 0b1c3f8..c46b786 100644 --- a/.codex/skills-index.json +++ b/.codex/skills-index.json @@ -219,7 +219,7 @@ "name": "mdr-745-specialist", "source": "../../ra-qm-team/mdr-745-specialist", "category": "ra-qm", - "description": "EU MDR 2017/745 regulation specialist and consultant for medical device requirement management. Provides comprehensive MDR compliance expertise, gap analysis, technical documentation guidance, clinical evidence requirements, and post-market surveillance implementation. Use for MDR compliance assessment, classification decisions, technical file preparation, and regulatory requirement interpretation." + "description": "EU MDR 2017/745 compliance specialist for medical device classification, technical documentation, clinical evidence, and post-market surveillance. Covers Annex VIII classification rules, Annex II/III technical files, Annex XIV clinical evaluation, and EUDAMED integration." }, { "name": "qms-audit-expert", diff --git a/ra-qm-team/mdr-745-specialist/SKILL.md b/ra-qm-team/mdr-745-specialist/SKILL.md index 8041c43..45be2b3 100644 --- a/ra-qm-team/mdr-745-specialist/SKILL.md +++ b/ra-qm-team/mdr-745-specialist/SKILL.md @@ -1,195 +1,335 @@ --- name: mdr-745-specialist -description: EU MDR 2017/745 regulation specialist and consultant for medical device requirement management. Provides comprehensive MDR compliance expertise, gap analysis, technical documentation guidance, clinical evidence requirements, and post-market surveillance implementation. Use for MDR compliance assessment, classification decisions, technical file preparation, and regulatory requirement interpretation. +description: EU MDR 2017/745 compliance specialist for medical device classification, technical documentation, clinical evidence, and post-market surveillance. Covers Annex VIII classification rules, Annex II/III technical files, Annex XIV clinical evaluation, and EUDAMED integration. +triggers: + - MDR compliance + - EU MDR + - medical device classification + - Annex VIII + - technical documentation + - clinical evaluation + - PMCF + - EUDAMED + - UDI + - notified body --- -# Senior MDR 2017/745 Specialist and Consultant +# MDR 2017/745 Specialist -Expert-level EU MDR 2017/745 compliance specialist with comprehensive knowledge of medical device regulation requirements, technical documentation, clinical evidence, and post-market surveillance obligations. +EU MDR compliance patterns for medical device classification, technical documentation, and clinical evidence. -## Core MDR Competencies +--- -### 1. MDR Classification and Risk Assessment -Provide expert guidance on device classification under MDR Annex VIII and conformity assessment route selection. +## Table of Contents -**Classification Decision Framework:** -1. **Preliminary Classification Assessment** - - Apply MDR Annex VIII classification rules - - Consider device duration, invasiveness, and body system interaction - - Evaluate software classification per MDCG 2019-11 - - **Decision Point**: Determine appropriate classification class (I, IIa, IIb, III) +- [Device Classification Workflow](#device-classification-workflow) +- [Technical Documentation](#technical-documentation) +- [Clinical Evidence](#clinical-evidence) +- [Post-Market Surveillance](#post-market-surveillance) +- [EUDAMED and UDI](#eudamed-and-udi) +- [Reference Documentation](#reference-documentation) +- [Tools](#tools) -2. **Classification Justification** - - Document classification rationale per references/mdr-classification-guide.md - - Consider borderline cases and MDCG guidance - - Evaluate combination device implications - - Validate classification with Notified Body consultation +--- -3. **Conformity Assessment Route Selection** - - **Class I**: Self-certification under Annex II - - **Class IIa**: Module C2 + Annex V (Notified Body involvement) - - **Class IIb**: Module B + C or D (Type examination + production) - - **Class III**: Module B + C or D (Full quality assurance) +## Device Classification Workflow -### 2. Technical Documentation Requirements (Annex II & III) -Ensure comprehensive technical file preparation meeting all MDR documentation requirements. +Classify device under MDR Annex VIII: + +1. Identify device duration (transient, short-term, long-term) +2. Determine invasiveness level (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 +6. For software, apply MDCG 2019-11 algorithm +7. Document classification rationale +8. **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 | +| Risk | Lowest | Low-medium | Medium-high | Highest | + +### Software Classification (MDCG 2019-11) + +| Information Use | Condition Severity | Class | +|-----------------|-------------------|-------| +| Informs decision | Non-serious | IIa | +| Informs decision | Serious | IIb | +| Drives/treats | Critical | III | + +### Classification Examples + +**Example 1: Absorbable Surgical Suture** +- Rule 8 (implantable, long-term) +- Duration: > 30 days (absorbed) +- Contact: General tissue +- Classification: **Class IIb** + +**Example 2: AI Diagnostic Software** +- Rule 11 + MDCG 2019-11 +- Function: Diagnoses serious condition +- Classification: **Class IIb** + +**Example 3: Cardiac Pacemaker** +- Rule 8 (implantable) +- Contact: Central circulatory system +- Classification: **Class III** + +--- + +## Technical Documentation + +Prepare technical file per Annex II and III: + +1. Create device description (variants, accessories, intended purpose) +2. Develop labeling (Article 13 requirements, IFU) +3. Document design and manufacturing process +4. Complete GSPR compliance matrix +5. Prepare benefit-risk analysis +6. Compile verification and validation evidence +7. Integrate risk management file (ISO 14971) +8. **Validation:** Technical file reviewed for completeness + +### Technical File Structure -**Technical Documentation Structure:** ``` ANNEX II TECHNICAL DOCUMENTATION -├── General Information -│ ├── Device identification and UDI-DI -│ ├── Manufacturer and authorized representative info -│ ├── Intended purpose and clinical condition -│ └── Device description and variants -├── Information to be Supplied by Manufacturer -│ ├── Label and instructions for use -│ ├── Clinical evaluation and post-market clinical follow-up -│ ├── Risk management documentation -│ └── Product verification and validation -├── Design and Manufacturing Information -│ ├── Quality management system documentation -│ ├── Design and development process -│ ├── Manufacturing process description -│ └── Identification and traceability procedures -└── General Safety and Performance Requirements - ├── Solutions adopted for GSPR compliance - ├── Benefit-risk analysis and risk management - ├── Product lifecycle and post-market surveillance - └── Clinical evidence and evaluation +├── Device description and UDI-DI +├── Label and instructions for use +├── Design and manufacturing info +├── GSPR compliance matrix +├── Benefit-risk analysis +├── Verification and validation +└── Clinical evaluation report ``` -### 3. Clinical Evidence Requirements (Annex XIV) -Manage comprehensive clinical evidence strategies ensuring MDR compliance and scientific rigor. +### GSPR Compliance Checklist -**Clinical Evidence Pathway Selection:** -1. **Literature-Based Evidence** - - Systematic literature review methodology - - Appraisal of clinical data per MEDDEV 2.7/1 rev.4 - - Gap analysis and additional evidence requirements - - **Decision Point**: Determine if literature is sufficient or clinical investigation required +| Requirement | Evidence | Status | +|-------------|----------|--------| +| Safe design (GSPR 1-3) | Risk management file | ☐ | +| Chemical properties (GSPR 10.1) | Biocompatibility report | ☐ | +| Infection risk (GSPR 10.2) | Sterilization validation | ☐ | +| Software requirements (GSPR 17) | IEC 62304 documentation | ☐ | +| Labeling (GSPR 23) | Label artwork, IFU | ☐ | -2. **Clinical Investigation Requirements** - - **For significant changes** or **novel devices** - - **For Class III implantable devices** (Article 61) - - Clinical investigation plan development - - Ethics committee and competent authority approvals +### Conformity Assessment Routes -3. **Post-Market Clinical Follow-up (PMCF)** - - **PMCF Plan** development per Annex XIV Part B - - **PMCF Evaluation Report** (PMCF-ER) preparation - - Clinical evaluation report updating requirements - - Integration with post-market surveillance system +| Class | Route | NB Involvement | +|-------|-------|----------------| +| I | Annex II self-declaration | None | +| Is/Im | Annex II + IX/XI | Sterile/measuring aspects | +| 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 | -### 4. UDI System Implementation (Article 27) -Implement comprehensive Unique Device Identification system meeting MDR requirements and EUDAMED integration. +--- -**UDI Implementation Workflow:** -1. **UDI Strategy Development** - - UDI-DI assignment for device variants - - UDI-PI requirements for higher risk devices - - EUDAMED registration timeline planning - - Labeling compliance verification +## Clinical Evidence -2. **EUDAMED Registration** - - **Actor registration** (manufacturers, authorized representatives) - - **Device registration** and UDI-DI assignment - - **Certificate registration** (Notified Body certificates) - - **Clinical investigation** and serious incident reporting +Develop clinical evidence strategy per Annex XIV: -## MDR Compliance Management +1. Define clinical claims and endpoints +2. Conduct systematic literature search +3. Appraise clinical data quality +4. Assess equivalence (technical, biological, clinical) +5. Identify evidence gaps +6. Determine if clinical investigation required +7. Prepare Clinical Evaluation Report (CER) +8. **Validation:** CER reviewed by qualified evaluator -### Gap Analysis and Transition Planning -Conduct systematic gap assessments against current MDR requirements and develop comprehensive transition strategies. +### Evidence Requirements by Class -**Gap Analysis Framework:** -1. **Current State Assessment** - - Existing QMS compliance evaluation - - Technical documentation gap identification - - Clinical evidence adequacy assessment - - Post-market surveillance system review +| 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) | -2. **MDR Requirement Mapping** - - **For existing devices**: Legacy directive vs. MDR requirements - - **For new devices**: Full MDR compliance roadmap - - **For software**: Software-specific MDR requirements per MDCG guidance - - Resource and timeline impact assessment +### Clinical Evaluation Report Structure -### Post-Market Surveillance (Chapter VII) -Establish robust post-market surveillance systems meeting MDR requirements for continuous safety monitoring. +``` +CER CONTENTS +├── Executive summary +├── Device scope and intended purpose +├── Clinical background (state of the art) +├── Literature search methodology +├── Data appraisal and analysis +├── Safety and performance conclusions +├── Benefit-risk determination +└── PMCF plan summary +``` -**PMS System Components:** -- **PMS Plan** development per Article 84 -- **Periodic Safety Update Report (PSUR)** preparation -- **Serious incident reporting** to competent authorities -- **Field safety corrective actions (FSCA)** management -- **Trend reporting** and signal detection +### Qualified Evaluator Requirements -### Economic Operator Obligations -Ensure compliance with expanded economic operator responsibilities under MDR. +- Medical degree or equivalent healthcare qualification +- 4+ years clinical experience in relevant field +- Training in clinical evaluation methodology +- Understanding of MDR requirements -**Key Obligations Management:** -- **Manufacturer obligations** (Article 10) -- **Authorized representative duties** (Article 11) -- **Importer responsibilities** (Article 13) -- **Distributor obligations** (Article 14) -- **Person responsible for regulatory compliance** (Article 15) +--- + +## Post-Market Surveillance + +Establish PMS system per Chapter VII: + +1. Develop PMS plan (Article 84) +2. Define data collection methods +3. Establish complaint handling procedures +4. Create vigilance reporting process +5. Plan Periodic Safety Update Reports (PSUR) +6. Integrate with PMCF activities +7. Define trend analysis and signal detection +8. **Validation:** PMS system audited annually + +### PMS System Components + +| Component | Requirement | Frequency | +|-----------|-------------|-----------| +| PMS Plan | Article 84 | Maintain current | +| PSUR | Class IIa and higher | Per class schedule | +| PMCF Plan | Annex XIV Part B | Update with CER | +| PMCF Report | Annex XIV Part B | Annual (Class III) | +| Vigilance | Articles 87-92 | As events occur | + +### PSUR Schedule + +| Class | Frequency | +|-------|-----------| +| Class III | Annual | +| Class IIb implantable | Annual | +| Class IIb | Every 2 years | +| Class IIa | When necessary | + +### Serious Incident Reporting + +| Timeline | Requirement | +|----------|-------------| +| 2 days | Serious public health threat | +| 10 days | Death or serious deterioration | +| 15 days | Other serious incidents | + +--- + +## EUDAMED and UDI + +Implement UDI system per Article 27: + +1. Obtain issuing entity code (GS1, HIBCC, ICCBBA) +2. Assign UDI-DI to each device variant +3. Assign UDI-PI (production identifier) +4. Apply UDI carrier to labels (AIDC + HRI) +5. Register actor in EUDAMED +6. Register devices in EUDAMED +7. Upload certificates when available +8. **Validation:** UDI verified on sample labels + +### EUDAMED Modules + +| Module | Content | Actor | +|--------|---------|-------| +| Actor | Company registration | Manufacturer, AR | +| UDI/Device | Device and variant data | Manufacturer | +| Certificates | NB certificates | Notified Body | +| Clinical Investigation | Study registration | Sponsor | +| Vigilance | Incident reports | Manufacturer | +| Market Surveillance | Authority actions | Competent Authority | + +### UDI Label Requirements + +Required elements per Article 13: + +- [ ] UDI-DI (device identifier) +- [ ] UDI-PI (production identifier) for Class II+ +- [ ] AIDC format (barcode/RFID) +- [ ] HRI format (human-readable) +- [ ] Manufacturer name and address +- [ ] Lot/serial number +- [ ] Expiration date (if applicable) + +--- + +## Reference Documentation + +### MDR Classification Guide + +`references/mdr-classification-guide.md` contains: + +- Complete Annex VIII classification rules (Rules 1-22) +- Software classification per MDCG 2019-11 +- Worked classification examples +- Conformity assessment route selection + +### Clinical Evidence Requirements + +`references/clinical-evidence-requirements.md` contains: + +- Clinical evidence framework and hierarchy +- Literature search methodology +- Clinical Evaluation Report structure +- PMCF plan and evaluation report guidance + +### Technical Documentation Templates + +`references/technical-documentation-templates.md` contains: + +- Annex II and III content requirements +- Design History File structure +- GSPR compliance matrix template +- Declaration of Conformity template +- Notified Body submission checklist + +--- + +## Tools + +### MDR Gap Analyzer + +```bash +# Quick gap analysis +python scripts/mdr_gap_analyzer.py --device "Device Name" --class IIa + +# JSON output for integration +python scripts/mdr_gap_analyzer.py --device "Device Name" --class III --output json + +# Interactive assessment +python scripts/mdr_gap_analyzer.py --interactive +``` + +Analyzes device against MDR requirements, identifies compliance gaps, generates prioritized recommendations. + +**Output includes:** +- Requirements checklist by category +- Gap identification with priorities +- Critical gap highlighting +- Compliance roadmap recommendations + +--- ## Notified Body Interface -### Notified Body Selection and Management -Provide strategic guidance on Notified Body selection and relationship management throughout the conformity assessment process. +### Selection Criteria -**Notified Body Engagement Strategy:** -1. **Selection Criteria Assessment** - - Technical competency evaluation - - Capacity and timeline considerations - - Geographic scope and market access - - Fee structure and commercial terms +| Factor | Considerations | +|--------|----------------| +| Designation scope | Covers your device type | +| Capacity | Timeline for initial audit | +| Geographic reach | Markets you need to access | +| Technical expertise | Experience with your technology | +| Fee structure | Transparency, predictability | -2. **Pre-submission Activities** - - Pre-submission meetings and consultations - - Technical documentation readiness assessment - - Timeline and milestone planning - - **Decision Point**: Determine submission readiness and timing +### Pre-Submission Checklist -### Audit and Assessment Management -Coordinate Notified Body audits and assessments ensuring successful outcomes and certificate maintenance. - -**Audit Preparation Protocol:** -- **Documentation preparation** and organization -- **Personnel training** and role assignment -- **Facility readiness** and compliance verification -- **Mock audit** execution and improvement implementation - -## Regulatory Intelligence and Updates - -### MDR Guidance Monitoring -Maintain current awareness of evolving MDR guidance and regulatory expectations. - -**Guidance Tracking System:** -- **MDCG guidance** monitoring and impact assessment -- **Notified Body guidance** evaluation and implementation -- **Competent authority positions** and national implementations -- **Industry best practices** and lessons learned integration - -## Resources - -### scripts/ -- `mdr-gap-analysis.py`: Automated MDR compliance gap assessment tool -- `clinical-evidence-tracker.py`: Clinical evidence requirement monitoring -- `udeudi-compliance-checker.py`: UDI and EUDAMED compliance verification -- `pms-reporting-automation.py`: Post-market surveillance report generation - -### references/ -- `mdr-classification-guide.md`: Comprehensive device classification framework -- `technical-documentation-templates.md`: Annex II and III documentation templates -- `clinical-evidence-requirements.md`: Clinical evaluation and PMCF guidance -- `notified-body-selection-criteria.md`: NB evaluation and selection framework -- `mdcg-guidance-library.md`: Current MDCG guidance compilation - -### assets/ -- `mdr-templates/`: Technical file, clinical evaluation, and PMS plan templates -- `gap-analysis-checklists/`: MDR compliance assessment tools -- `eudamed-forms/`: EUDAMED registration and reporting templates -- `training-materials/`: MDR training presentations and compliance guides +- [ ] Technical documentation complete +- [ ] GSPR matrix fully addressed +- [ ] Risk management file current +- [ ] Clinical evaluation report complete +- [ ] QMS (ISO 13485) certified +- [ ] Labeling and IFU finalized +- [ ] **Validation:** Internal gap assessment complete diff --git a/ra-qm-team/mdr-745-specialist/assets/example_asset.txt b/ra-qm-team/mdr-745-specialist/assets/example_asset.txt deleted file mode 100644 index d0ac204..0000000 --- a/ra-qm-team/mdr-745-specialist/assets/example_asset.txt +++ /dev/null @@ -1,24 +0,0 @@ -# Example Asset File - -This placeholder represents where asset files would be stored. -Replace with actual asset files (templates, images, fonts, etc.) or delete if not needed. - -Asset files are NOT intended to be loaded into context, but rather used within -the output Claude produces. - -Example asset files from other skills: -- Brand guidelines: logo.png, slides_template.pptx -- Frontend builder: hello-world/ directory with HTML/React boilerplate -- Typography: custom-font.ttf, font-family.woff2 -- Data: sample_data.csv, test_dataset.json - -## Common Asset Types - -- Templates: .pptx, .docx, boilerplate directories -- Images: .png, .jpg, .svg, .gif -- Fonts: .ttf, .otf, .woff, .woff2 -- Boilerplate code: Project directories, starter files -- Icons: .ico, .svg -- Data files: .csv, .json, .xml, .yaml - -Note: This is a text placeholder. Actual assets can be any file type. diff --git a/ra-qm-team/mdr-745-specialist/references/api_reference.md b/ra-qm-team/mdr-745-specialist/references/api_reference.md deleted file mode 100644 index 0b93184..0000000 --- a/ra-qm-team/mdr-745-specialist/references/api_reference.md +++ /dev/null @@ -1,34 +0,0 @@ -# Reference Documentation for Mdr 745 Specialist - -This is a placeholder for detailed reference documentation. -Replace with actual reference content or delete if not needed. - -Example real reference docs from other skills: -- product-management/references/communication.md - Comprehensive guide for status updates -- product-management/references/context_building.md - Deep-dive on gathering context -- bigquery/references/ - API references and query examples - -## When Reference Docs Are Useful - -Reference docs are ideal for: -- Comprehensive API documentation -- Detailed workflow guides -- Complex multi-step processes -- Information too lengthy for main SKILL.md -- Content that's only needed for specific use cases - -## Structure Suggestions - -### API Reference Example -- Overview -- Authentication -- Endpoints with examples -- Error codes -- Rate limits - -### Workflow Guide Example -- Prerequisites -- Step-by-step instructions -- Common patterns -- Troubleshooting -- Best practices diff --git a/ra-qm-team/mdr-745-specialist/references/clinical-evidence-requirements.md b/ra-qm-team/mdr-745-specialist/references/clinical-evidence-requirements.md new file mode 100644 index 0000000..63d2661 --- /dev/null +++ b/ra-qm-team/mdr-745-specialist/references/clinical-evidence-requirements.md @@ -0,0 +1,303 @@ +# 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 diff --git a/ra-qm-team/mdr-745-specialist/references/mdr-classification-guide.md b/ra-qm-team/mdr-745-specialist/references/mdr-classification-guide.md new file mode 100644 index 0000000..12a17b7 --- /dev/null +++ b/ra-qm-team/mdr-745-specialist/references/mdr-classification-guide.md @@ -0,0 +1,289 @@ +# 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 diff --git a/ra-qm-team/mdr-745-specialist/references/technical-documentation-templates.md b/ra-qm-team/mdr-745-specialist/references/technical-documentation-templates.md new file mode 100644 index 0000000..ba5f271 --- /dev/null +++ b/ra-qm-team/mdr-745-specialist/references/technical-documentation-templates.md @@ -0,0 +1,355 @@ +# Technical Documentation Templates + +MDR Annex II and III technical file structure and content requirements. + +--- + +## Table of Contents + +- [Technical Documentation Overview](#technical-documentation-overview) +- [Annex II Requirements](#annex-ii-requirements) +- [Annex III Additions](#annex-iii-additions) +- [Document Templates](#document-templates) +- [Notified Body Expectations](#notified-body-expectations) + +--- + +## Technical Documentation Overview + +### Documentation Hierarchy + +``` +TECHNICAL DOCUMENTATION +├── Device Description and Specification +├── Information Supplied by Manufacturer +├── Design and Manufacturing Information +├── General Safety and Performance Requirements +├── Benefit-Risk Analysis +├── Product Verification and Validation +├── Clinical Evaluation Report +└── Post-Market Surveillance Documentation +``` + +### Documentation by Phase + +| Phase | Required Documents | +|-------|-------------------| +| Design Input | User needs, design requirements, regulatory requirements | +| Design Development | Design specifications, drawings, BOM, software docs | +| Verification | Test protocols, test reports, design review records | +| Validation | Clinical data, usability data, biocompatibility | +| Transfer | Manufacturing specs, process validations | +| Post-Market | PMS plan, PMCF plan, vigilance procedures | + +--- + +## Annex II Requirements + +### Section 1: Device Description and Specification + +**1.1 Device Identification** + +``` +DEVICE IDENTIFICATION +├── Trade name(s) +├── General description of the device +├── Basic UDI-DI +├── Device identifier codes (internal + regulatory) +├── Intended purpose statement +├── Indications for use +├── Contraindications +├── Target population (patient, user) +├── Medical conditions intended to diagnose/treat +└── Principles of operation +``` + +**1.2 Device Variants and Accessories** + +| Element | Description | +|---------|-------------| +| Variant listing | All variants with identifiers | +| Configuration differences | Technical differences by variant | +| Accessories | Separate devices used together | +| Spare parts | Replaceable components | + +**1.3 Reference to Previous Generations** + +- Previous generation device identification +- Key modifications summary +- Clinical experience from prior device +- Justification for changes + +### Section 2: Information Supplied by Manufacturer + +**2.1 Label Requirements** + +Mandatory label elements per Article 13: + +- [ ] Device name or trade name +- [ ] Manufacturer name and address +- [ ] Authorized representative (if applicable) +- [ ] Lot/batch number or serial number +- [ ] UDI carrier (AIDC + HRI) +- [ ] Expiration date (if applicable) +- [ ] Storage/handling conditions +- [ ] Warnings and precautions +- [ ] CE mark with NB number (if applicable) +- [ ] Symbol meanings per EN ISO 15223-1 + +**2.2 Instructions for Use** + +IFU structure: + +``` +INSTRUCTIONS FOR USE +├── 1. Device Description +│ ├── Intended purpose +│ ├── Indications and contraindications +│ └── Principle of operation +├── 2. Warnings and Precautions +│ ├── Contraindicated uses +│ ├── Potential complications +│ └── Drug/device interactions +├── 3. User Instructions +│ ├── Unpacking and inspection +│ ├── Setup/installation +│ ├── Operating procedures +│ └── Cleaning/maintenance +├── 4. Technical Specifications +│ ├── Physical characteristics +│ ├── Performance characteristics +│ └── Environmental limits +├── 5. Troubleshooting +│ ├── Error codes/messages +│ └── Corrective actions +└── 6. Symbols Glossary +``` + +### Section 3: Design and Manufacturing Information + +**3.1 Design Process Documentation** + +| Document | Purpose | +|----------|---------| +| Design input | User needs, regulatory requirements | +| Design output | Specifications, drawings, software | +| Design review | Review records at key milestones | +| Design verification | Test protocols and results | +| Design validation | Clinical/usability evidence | +| Design transfer | Manufacturing readiness | +| Design changes | Change control records | + +**3.2 Manufacturing Process Description** + +``` +MANUFACTURING DOCUMENTATION +├── Process flow diagram +├── Manufacturing specifications +├── Facility and equipment qualification +├── Process validation protocols/reports +├── Environmental monitoring +├── Personnel training records +├── In-process controls +├── Final inspection/testing +├── Sterilization validation (if applicable) +└── Packaging validation +``` + +**3.3 Supplier and Subcontractor Information** + +- Approved supplier list +- Supplier qualification records +- Critical component specifications +- Incoming inspection procedures +- Supplier audit records + +### Section 4: General Safety and Performance Requirements + +**GSPR Compliance Checklist** + +| GSPR | Requirement | Evidence | +|------|-------------|----------| +| 1 | Safe design for intended use | Risk management file | +| 2 | Risk acceptable when weighed against benefits | Benefit-risk analysis | +| 3 | State of the art design | Literature review, standards | +| 4 | No compromise of clinical condition | Clinical evaluation | +| 5 | Transport and storage conditions | Shelf life testing | +| 6 | Acceptable undesirable effects | Risk-benefit analysis | +| 7 | CE marking conformity | Declaration of conformity | +| ... | Continue for all applicable GSPRs | | + +**GSPR Matrix Template** + +| GSPR # | Requirement Summary | Applicable? | Evidence Document | Status | +|--------|---------------------|-------------|-------------------|--------| +| 10.1 | Chemical properties | Yes/No/NA | Biocompatibility report | Complete | +| 10.2 | Infection risk | Yes/No/NA | Sterilization validation | Complete | +| 10.3 | Substances with carcinogenic risk | Yes/No/NA | Material specification | Complete | + +### Section 5: Benefit-Risk Analysis + +**Benefit-Risk Documentation** + +``` +BENEFIT-RISK ANALYSIS +├── 1. Intended Benefits +│ ├── Direct therapeutic benefits +│ ├── Diagnostic accuracy improvements +│ └── Patient outcome benefits +├── 2. Known Risks +│ ├── Identified hazards (from risk analysis) +│ ├── Risk control measures implemented +│ └── Residual risks +├── 3. Benefit-Risk Determination +│ ├── Qualitative analysis +│ ├── Quantitative analysis (if available) +│ └── Comparison to alternatives +└── 4. Conclusion + ├── Acceptability statement + └── Justification for residual risks +``` + +### Section 6: Product Verification and Validation + +**6.1 Verification Testing** + +| Test Category | Standards | Documentation | +|---------------|-----------|---------------| +| Electrical safety | IEC 60601-1 | Test protocol + report | +| EMC | IEC 60601-1-2 | EMC test report | +| Biocompatibility | ISO 10993 series | Biocompatibility evaluation | +| Software | IEC 62304 | Software verification report | +| Sterilization | ISO 11135/11137 | Sterility assurance | +| Packaging | ISO 11607 | Packaging validation | +| Shelf life | Accelerated aging | Stability study report | +| Usability | IEC 62366-1 | Usability engineering file | + +**6.2 Validation Evidence** + +- Clinical investigation data +- Literature-based clinical evidence +- Simulated use testing +- User feedback/complaint analysis +- Post-market surveillance data + +--- + +## Annex III Additions + +### Class III Specific Requirements + +Additional documentation for Class III devices: + +**Implant-Specific Requirements** + +- Implant card information +- Patient information leaflet +- Device tracking procedures +- Explant analysis capability + +**Drug-Device Combination** + +- Drug substance specification +- Drug compatibility testing +- Combined product assessment +- Pharmacovigilance interface + +--- + +## Document Templates + +### Design History File Index + +``` +DESIGN HISTORY FILE (DHF) +Document ID: DHF-[Product]-[Rev] + +1. DESIGN INPUT + 1.1 User Requirements Specification (URS) + 1.2 Regulatory Requirements Matrix + 1.3 Design Input Review Record + +2. DESIGN OUTPUT + 2.1 Product Specification + 2.2 Engineering Drawings + 2.3 Bill of Materials + 2.4 Software Documentation + +3. DESIGN VERIFICATION + 3.1 Verification Test Plan + 3.2 Verification Test Reports + 3.3 Traceability Matrix + +4. DESIGN VALIDATION + 4.1 Clinical Evaluation Report + 4.2 Usability Engineering File + 4.3 Biocompatibility Evaluation + +5. DESIGN TRANSFER + 5.1 Manufacturing Procedures + 5.2 Process Validation Reports + 5.3 Supplier Qualification + +6. DESIGN REVIEWS + 6.1 Design Review Records + 6.2 Risk Management Review + 6.3 Final Design Release +``` + +### Declaration of Conformity Template + +``` +EU DECLARATION OF CONFORMITY + +We, [Manufacturer Name] +Address: [Full address] + +declare under our sole responsibility that the device: + +Device name: [Trade name] +Device description: [Description] +Basic UDI-DI: [UDI-DI] +Classification: [Class I/IIa/IIb/III] + +is in conformity with the provisions of: +- Regulation (EU) 2017/745 + +Applicable standards: +- [List harmonized standards] + +Notified Body: [NB name and number] (if applicable) +Certificate number: [Certificate number] + +Place and date: [Location, Date] +Signature: [Authorized signatory] +Name and function: [Name, Title] +``` + +--- + +## Notified Body Expectations + +### Common NB Findings + +| Finding Area | Common Issue | Prevention | +|--------------|--------------|------------| +| GSPR matrix | Incomplete, no evidence links | Complete matrix with references | +| Risk management | Not integrated with design | Update throughout development | +| Clinical evaluation | Insufficient literature search | Systematic search with PICO | +| IFU | Missing warnings | Risk-based IFU content | +| Traceability | Design to requirements gaps | Maintain traceability matrix | + +### Pre-Submission Checklist + +Before Notified Body submission: + +- [ ] Technical documentation complete +- [ ] GSPR checklist fully addressed +- [ ] Risk management file current +- [ ] Clinical evaluation report complete +- [ ] QMS documentation ready +- [ ] Design verification complete +- [ ] Design validation complete +- [ ] Labeling and IFU finalized +- [ ] Declaration of conformity prepared +- [ ] **Validation:** Internal review completed diff --git a/ra-qm-team/mdr-745-specialist/scripts/example.py b/ra-qm-team/mdr-745-specialist/scripts/example.py deleted file mode 100755 index 890b3fd..0000000 --- a/ra-qm-team/mdr-745-specialist/scripts/example.py +++ /dev/null @@ -1,19 +0,0 @@ -#!/usr/bin/env python3 -""" -Example helper script for mdr-745-specialist - -This is a placeholder script that can be executed directly. -Replace with actual implementation or delete if not needed. - -Example real scripts from other skills: -- pdf/scripts/fill_fillable_fields.py - Fills PDF form fields -- pdf/scripts/convert_pdf_to_images.py - Converts PDF pages to images -""" - -def main(): - print("This is an example script for mdr-745-specialist") - # TODO: Add actual script logic here - # This could be data processing, file conversion, API calls, etc. - -if __name__ == "__main__": - main() diff --git a/ra-qm-team/mdr-745-specialist/scripts/mdr_gap_analyzer.py b/ra-qm-team/mdr-745-specialist/scripts/mdr_gap_analyzer.py new file mode 100644 index 0000000..bdc2720 --- /dev/null +++ b/ra-qm-team/mdr-745-specialist/scripts/mdr_gap_analyzer.py @@ -0,0 +1,511 @@ +#!/usr/bin/env python3 +""" +MDR Gap Analyzer - EU MDR 2017/745 Compliance Gap Assessment Tool + +Analyzes device classification, identifies documentation gaps, and generates +compliance roadmap for EU MDR transition. + +Usage: + python mdr_gap_analyzer.py --device "Device Name" --class IIa + python mdr_gap_analyzer.py --device "Device Name" --class III --output json + python mdr_gap_analyzer.py --interactive +""" + +import argparse +import json +import sys +from dataclasses import dataclass, field, asdict +from datetime import datetime +from typing import List, Dict, Optional +from enum import Enum + + +class DeviceClass(Enum): + I = "I" + I_STERILE = "Is" + I_MEASURING = "Im" + IIA = "IIa" + IIB = "IIb" + III = "III" + + +class GapStatus(Enum): + NOT_STARTED = "Not Started" + IN_PROGRESS = "In Progress" + COMPLETE = "Complete" + NOT_APPLICABLE = "N/A" + + +@dataclass +class GapItem: + requirement: str + category: str + description: str + status: GapStatus = GapStatus.NOT_STARTED + priority: str = "Medium" + evidence_needed: List[str] = field(default_factory=list) + notes: str = "" + + +@dataclass +class GapAnalysisResult: + device_name: str + device_class: str + analysis_date: str + total_requirements: int + gaps_identified: int + completion_percentage: float + gaps: List[Dict] + recommendations: List[str] + critical_gaps: List[str] + + +class MDRGapAnalyzer: + """Analyzer for EU MDR 2017/745 compliance gaps.""" + + # MDR Requirements by category + REQUIREMENTS = { + "technical_documentation": [ + GapItem( + requirement="Annex II - Device Description", + category="Technical Documentation", + description="Complete device description including variants, accessories, intended purpose", + priority="High", + evidence_needed=["Device specification", "Intended purpose statement", "Variant listing"] + ), + GapItem( + requirement="Annex II - Information Supplied", + category="Technical Documentation", + description="Label and IFU meeting Article 13 requirements", + priority="High", + evidence_needed=["Label artwork", "Instructions for use", "Symbol glossary"] + ), + GapItem( + requirement="Annex II - Design and Manufacturing", + category="Technical Documentation", + description="Design history file and manufacturing documentation", + priority="High", + evidence_needed=["Design history file", "Process flow diagram", "Validation reports"] + ), + GapItem( + requirement="Annex II - GSPR Compliance", + category="Technical Documentation", + description="General Safety and Performance Requirements checklist", + priority="Critical", + evidence_needed=["GSPR matrix", "Standard compliance evidence", "Risk management file"] + ), + ], + "clinical_evaluation": [ + GapItem( + requirement="Annex XIV Part A - Clinical Evaluation", + category="Clinical Evaluation", + description="Clinical evaluation report with systematic literature review", + priority="Critical", + evidence_needed=["Clinical evaluation report", "Literature search protocol", "Data appraisal"] + ), + GapItem( + requirement="Annex XIV Part B - PMCF", + category="Clinical Evaluation", + description="Post-market clinical follow-up plan and evaluation report", + priority="High", + evidence_needed=["PMCF plan", "PMCF evaluation report", "Residual risk assessment"] + ), + GapItem( + requirement="Qualified Person for CER", + category="Clinical Evaluation", + description="Clinical evaluation by qualified evaluator per Annex XIV", + priority="High", + evidence_needed=["Evaluator CV", "Qualification evidence", "Signed CER"] + ), + ], + "risk_management": [ + GapItem( + requirement="ISO 14971 Risk Management", + category="Risk Management", + description="Complete risk management file per ISO 14971:2019", + priority="Critical", + evidence_needed=["Risk management plan", "Risk analysis", "Risk evaluation", "Risk control"] + ), + GapItem( + requirement="Benefit-Risk Analysis", + category="Risk Management", + description="Documented benefit-risk determination", + priority="High", + evidence_needed=["Benefit-risk analysis document", "Residual risk acceptability"] + ), + ], + "quality_management": [ + GapItem( + requirement="ISO 13485 QMS", + category="Quality Management", + description="Quality management system conforming to ISO 13485:2016", + priority="Critical", + evidence_needed=["QMS manual", "Process documentation", "Internal audit records"] + ), + GapItem( + requirement="Post-Market Surveillance", + category="Quality Management", + description="PMS system per Article 83-86", + priority="High", + evidence_needed=["PMS plan", "PSUR (if required)", "Vigilance procedures"] + ), + ], + "udi_eudamed": [ + GapItem( + requirement="UDI System", + category="UDI/EUDAMED", + description="Unique Device Identification per Article 27", + priority="High", + evidence_needed=["UDI-DI assignment", "Label with UDI carrier", "GUDID/EUDAMED registration"] + ), + GapItem( + requirement="EUDAMED Registration", + category="UDI/EUDAMED", + description="Actor, device, and certificate registration in EUDAMED", + priority="Medium", + evidence_needed=["Actor registration", "Device registration", "Certificate upload"] + ), + ], + "notified_body": [ + GapItem( + requirement="Notified Body Selection", + category="Notified Body", + description="Selection and engagement of MDR-designated Notified Body", + priority="Critical", + evidence_needed=["NB selection criteria", "NB engagement letter", "Audit schedule"] + ), + GapItem( + requirement="Conformity Assessment", + category="Notified Body", + description="Completion of appropriate conformity assessment procedure", + priority="Critical", + evidence_needed=["Application dossier", "Technical documentation submission", "Certificate"] + ), + ], + } + + # Class-specific requirements + CLASS_REQUIREMENTS = { + DeviceClass.III: [ + GapItem( + requirement="Annex III - Class III Additions", + category="Technical Documentation", + description="Additional documentation for Class III devices", + priority="Critical", + evidence_needed=["Implant card", "Patient information", "Device tracking"] + ), + GapItem( + requirement="Clinical Investigation", + category="Clinical Evaluation", + description="Clinical investigation per Article 61 (unless equivalent device)", + priority="Critical", + evidence_needed=["Clinical investigation plan", "Ethics approval", "Clinical study report"] + ), + ], + DeviceClass.IIB: [ + GapItem( + requirement="Implantable Device Documentation", + category="Technical Documentation", + description="Additional requirements for implantable Class IIb devices", + priority="High", + evidence_needed=["Implant card (if implantable)", "Long-term safety data"] + ), + ], + } + + def __init__(self, device_name: str, device_class: DeviceClass): + self.device_name = device_name + self.device_class = device_class + self.gaps: List[GapItem] = [] + self._build_requirements_list() + + def _build_requirements_list(self): + """Build complete requirements list based on device class.""" + # Add all base requirements + for category_gaps in self.REQUIREMENTS.values(): + for gap in category_gaps: + self.gaps.append(GapItem( + requirement=gap.requirement, + category=gap.category, + description=gap.description, + priority=gap.priority, + evidence_needed=gap.evidence_needed.copy() + )) + + # Add class-specific requirements + if self.device_class in self.CLASS_REQUIREMENTS: + for gap in self.CLASS_REQUIREMENTS[self.device_class]: + self.gaps.append(GapItem( + requirement=gap.requirement, + category=gap.category, + description=gap.description, + priority=gap.priority, + evidence_needed=gap.evidence_needed.copy() + )) + + # Class I self-certification: NB not required + if self.device_class == DeviceClass.I: + for gap in self.gaps: + if gap.category == "Notified Body": + gap.status = GapStatus.NOT_APPLICABLE + + def update_gap_status(self, requirement: str, status: GapStatus, notes: str = ""): + """Update status of a specific gap.""" + for gap in self.gaps: + if gap.requirement == requirement: + gap.status = status + gap.notes = notes + break + + def analyze(self) -> GapAnalysisResult: + """Perform gap analysis and generate results.""" + applicable_gaps = [g for g in self.gaps if g.status != GapStatus.NOT_APPLICABLE] + complete_gaps = [g for g in applicable_gaps if g.status == GapStatus.COMPLETE] + + completion = (len(complete_gaps) / len(applicable_gaps) * 100) if applicable_gaps else 0 + + # Identify critical gaps + critical_gaps = [ + g.requirement for g in applicable_gaps + if g.priority == "Critical" and g.status != GapStatus.COMPLETE + ] + + # Generate recommendations + recommendations = self._generate_recommendations() + + return GapAnalysisResult( + device_name=self.device_name, + device_class=self.device_class.value, + analysis_date=datetime.now().isoformat(), + total_requirements=len(applicable_gaps), + gaps_identified=len(applicable_gaps) - len(complete_gaps), + completion_percentage=round(completion, 1), + gaps=[{ + "requirement": g.requirement, + "category": g.category, + "status": g.status.value, + "priority": g.priority, + "evidence_needed": g.evidence_needed + } for g in applicable_gaps], + recommendations=recommendations, + critical_gaps=critical_gaps + ) + + def _generate_recommendations(self) -> List[str]: + """Generate prioritized recommendations.""" + recommendations = [] + + # Check for critical gaps + critical_incomplete = [ + g for g in self.gaps + if g.priority == "Critical" and g.status not in [GapStatus.COMPLETE, GapStatus.NOT_APPLICABLE] + ] + + if critical_incomplete: + recommendations.append( + f"CRITICAL: {len(critical_incomplete)} critical requirements not complete. " + "Address immediately to proceed with conformity assessment." + ) + + # Check clinical evaluation + cer_gap = next((g for g in self.gaps if "Clinical Evaluation" in g.requirement), None) + if cer_gap and cer_gap.status != GapStatus.COMPLETE: + recommendations.append( + "Clinical Evaluation Report (CER) is incomplete. " + "This is required before Notified Body submission." + ) + + # Check for Class III specific + if self.device_class == DeviceClass.III: + ci_gap = next((g for g in self.gaps if "Clinical Investigation" in g.requirement), None) + if ci_gap and ci_gap.status != GapStatus.COMPLETE: + recommendations.append( + "Class III device requires clinical investigation per Article 61 " + "unless equivalence can be demonstrated." + ) + + # Check EUDAMED + udi_gap = next((g for g in self.gaps if "UDI System" in g.requirement), None) + if udi_gap and udi_gap.status != GapStatus.COMPLETE: + recommendations.append( + "Implement UDI system and plan for EUDAMED registration. " + "Required for placing device on EU market." + ) + + return recommendations + + +def format_text_output(result: GapAnalysisResult) -> str: + """Format analysis result as text.""" + lines = [ + "=" * 60, + "MDR 2017/745 GAP ANALYSIS REPORT", + "=" * 60, + f"Device: {result.device_name}", + f"Class: {result.device_class}", + f"Date: {result.analysis_date[:10]}", + "", + "-" * 60, + "SUMMARY", + "-" * 60, + f"Total Requirements: {result.total_requirements}", + f"Gaps Identified: {result.gaps_identified}", + f"Completion: {result.completion_percentage}%", + "", + ] + + if result.critical_gaps: + lines.extend([ + "-" * 60, + "CRITICAL GAPS (Address Immediately)", + "-" * 60, + ]) + for gap in result.critical_gaps: + lines.append(f" * {gap}") + lines.append("") + + lines.extend([ + "-" * 60, + "GAP DETAILS BY CATEGORY", + "-" * 60, + ]) + + # Group by category + categories = {} + for gap in result.gaps: + cat = gap["category"] + if cat not in categories: + categories[cat] = [] + categories[cat].append(gap) + + for category, gaps in categories.items(): + lines.append(f"\n{category}:") + for gap in gaps: + status_mark = "✓" if gap["status"] == "Complete" else "○" + lines.append(f" [{status_mark}] {gap['requirement']} ({gap['priority']})") + + lines.extend([ + "", + "-" * 60, + "RECOMMENDATIONS", + "-" * 60, + ]) + for i, rec in enumerate(result.recommendations, 1): + lines.append(f"{i}. {rec}") + + lines.append("=" * 60) + return "\n".join(lines) + + +def interactive_mode(): + """Run interactive gap analysis session.""" + print("=" * 60) + print("MDR 2017/745 Gap Analysis - Interactive Mode") + print("=" * 60) + + device_name = input("\nDevice name: ").strip() + if not device_name: + device_name = "Unnamed Device" + + print("\nDevice classes:") + print(" 1. Class I") + print(" 2. Class I (sterile)") + print(" 3. Class I (measuring)") + print(" 4. Class IIa") + print(" 5. Class IIb") + print(" 6. Class III") + + class_map = { + "1": DeviceClass.I, + "2": DeviceClass.I_STERILE, + "3": DeviceClass.I_MEASURING, + "4": DeviceClass.IIA, + "5": DeviceClass.IIB, + "6": DeviceClass.III, + } + + class_choice = input("\nSelect class (1-6): ").strip() + device_class = class_map.get(class_choice, DeviceClass.IIA) + + analyzer = MDRGapAnalyzer(device_name, device_class) + + print("\nFor each requirement, enter status:") + print(" c = Complete") + print(" i = In Progress") + print(" n = Not Started (default)") + print(" x = Not Applicable") + print(" Enter = Skip (Not Started)") + print("") + + status_map = { + "c": GapStatus.COMPLETE, + "i": GapStatus.IN_PROGRESS, + "n": GapStatus.NOT_STARTED, + "x": GapStatus.NOT_APPLICABLE, + } + + for gap in analyzer.gaps: + if gap.status == GapStatus.NOT_APPLICABLE: + continue + status_input = input(f"{gap.requirement} [c/i/n/x]: ").strip().lower() + if status_input in status_map: + gap.status = status_map[status_input] + + result = analyzer.analyze() + print("\n" + format_text_output(result)) + + +def main(): + parser = argparse.ArgumentParser( + description="EU MDR 2017/745 Gap Analysis Tool" + ) + parser.add_argument("--device", type=str, help="Device name") + parser.add_argument( + "--class", + dest="device_class", + choices=["I", "Is", "Im", "IIa", "IIb", "III"], + help="Device classification" + ) + parser.add_argument( + "--output", + choices=["text", "json"], + default="text", + help="Output format" + ) + parser.add_argument( + "--interactive", + action="store_true", + help="Run in interactive mode" + ) + + args = parser.parse_args() + + if args.interactive: + interactive_mode() + return + + if not args.device or not args.device_class: + parser.print_help() + print("\nError: --device and --class required (or use --interactive)") + sys.exit(1) + + class_map = { + "I": DeviceClass.I, + "Is": DeviceClass.I_STERILE, + "Im": DeviceClass.I_MEASURING, + "IIa": DeviceClass.IIA, + "IIb": DeviceClass.IIB, + "III": DeviceClass.III, + } + + analyzer = MDRGapAnalyzer(args.device, class_map[args.device_class]) + result = analyzer.analyze() + + if args.output == "json": + print(json.dumps(asdict(result), indent=2)) + else: + print(format_text_output(result)) + + +if __name__ == "__main__": + main()