Senior MDR 2017/745 Specialist and Consultant

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.

Core MDR Competencies

1. MDR Classification and Risk Assessment

Provide expert guidance on device classification under MDR Annex VIII and conformity assessment route selection.

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)

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)

2. Technical Documentation Requirements (Annex II & III)

Ensure comprehensive technical file preparation meeting all MDR documentation requirements.

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

3. Clinical Evidence Requirements (Annex XIV)

Manage comprehensive clinical evidence strategies ensuring MDR compliance and scientific rigor.

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

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

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

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

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

MDR Compliance Management

Gap Analysis and Transition Planning

Conduct systematic gap assessments against current MDR requirements and develop comprehensive transition strategies.

Gap Analysis Framework:

1. Current State Assessment

   • Existing QMS compliance evaluation
   • Technical documentation gap identification
   • Clinical evidence adequacy assessment
   • Post-market surveillance system review

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

Post-Market Surveillance (Chapter VII)

Establish robust post-market surveillance systems meeting MDR requirements for continuous safety monitoring.

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

Economic Operator Obligations

Ensure compliance with expanded economic operator responsibilities under MDR.

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)

Notified Body Interface

Notified Body Selection and Management

Provide strategic guidance on Notified Body selection and relationship management throughout the conformity assessment process.

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

2. Pre-submission Activities

   • Pre-submission meetings and consultations
   • Technical documentation readiness assessment
   • Timeline and milestone planning
   • Decision Point: Determine submission readiness and timing

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_compliance_tracker.py: Comprehensive MDR compliance tracking dashboard with gap analysis, CE marking readiness assessment, and submission timeline generation. Tracks GSPR, technical documentation, clinical evaluation, PMS, and UDI compliance. Supports text/JSON/CSV output formats.
  • Usage: python mdr_compliance_tracker.py sample_mdr_requirements.json
  • Sample data included: sample_mdr_requirements.json
  • Features: Compliance scoring, blocking gap identification, effort estimation, timeline planning
• mdr-gap-analysis.py: Automated MDR compliance gap assessment tool (future)
• clinical-evidence-tracker.py: Clinical evidence requirement monitoring (future)
• udi-compliance-checker.py: UDI and EUDAMED compliance verification (future)
• pms-reporting-automation.py: Post-market surveillance report generation (future)

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

MDR Compliance Tracker Usage

Quick Start

# Basic usage - generates text dashboard
python mdr_compliance_tracker.py sample_mdr_requirements.json

# JSON output for system integration
python mdr_compliance_tracker.py mdr_data.json --output json

# CSV export for spreadsheet analysis
python mdr_compliance_tracker.py mdr_data.json -o csv -f compliance_report.csv

# Detailed verbose report
python mdr_compliance_tracker.py mdr_data.json -v

Input Data Format

The tracker requires a JSON file with the following structure:

{
  "metadata": {
    "device_name": "Device Name",
    "device_class": "CLASS_IIB",
    "manufacturer": "Company Name",
    "notified_body": "NB Identifier",
    "submission_target": "2026-06-30"
  },
  "requirements": [
    {
      "requirement_id": "GSPR-001",
      "annex_article": "ANNEX_I_GSPR",
      "title": "Requirement title",
      "description": "Detailed description",
      "priority": "BLOCKING",
      "status": "IN_PROGRESS",
      "device_class_applicable": ["CLASS_IIB"],
      "responsible_person": "Name - Role",
      "target_date": "2026-01-15",
      "completion_date": null,
      "evidence_location": "DHF/Path/To/Evidence",
      "gap_description": "What's missing",
      "mitigation_plan": "How to close gap",
      "verification_method": "How to verify",
      "estimated_effort_hours": 120,
      "blocking_for_ce_mark": true,
      "notes": "Additional context"
    }
  ],
  "pmcf_commitments": [
    {
      "pmcf_id": "PMCF-2026-001",
      "study_title": "Study name",
      "objective": "Study objective",
      "start_date": "2026-07-01",
      "target_completion": "2029-06-30",
      "status": "PLANNED",
      "data_sources": ["Registry", "Surveys"],
      "responsible_person": "Name - Role",
      "milestones": []
    }
  ],
  "udi_status": {
    "udi_di_assigned": true,
    "eudamed_registration_complete": false,
    "eudamed_target_date": "2026-04-30",
    "udi_on_device_label": true,
    "udi_on_packaging": true,
    "basic_udi_di_assigned": true,
    "responsible_person": "Name - Role",
    "status": "IN_PROGRESS",
    "notes": "UDI implementation notes"
  }
}

Key Features

1. Compliance Readiness Score

• Weighted scoring based on requirement status
• Overall percentage showing CE marking readiness
• Status weights: NOT_STARTED (0%), IN_PROGRESS (30%), PARTIALLY_COMPLIANT (60%), COMPLIANT (90%), VERIFIED (100%)

2. Blocking Gap Analysis

• Identifies requirements that must be complete for CE marking
• Prioritized list with responsible persons and target dates
• Gap descriptions and mitigation plans

3. CE Marking Readiness Assessment

• GSPR compliance status
• Technical documentation completeness
• Clinical evaluation status
• PMS system readiness
• UDI system compliance

4. Compliance by Annex/Article

• Annex I - GSPR
• Annex II/III - Technical Documentation
• Annex XIV / Article 61 - Clinical Evaluation
• Article 83-92 - Post-Market Surveillance
• Article 27 - UDI System

5. Effort Estimation

• Hours remaining by status (not started, in progress)
• Estimated weeks to completion
• Resource planning support

6. Submission Timeline

• Month-by-month requirement deadlines
• Blocking requirement counts
• Key deliverables overview

7. PMCF Tracking

• Post-market clinical follow-up study management
• Timeline and milestone tracking
• Data source documentation

8. UDI System Status

• UDI-DI assignment tracking
• EUDAMED registration status
• Labeling compliance verification

Output Formats

Text Format (Default)

• Human-readable dashboard
• Executive summary with key metrics
• Blocking gaps highlighted
• Compliance by annex breakdown
• Timeline visualization

JSON Format

• Machine-readable structured data
• Full metadata and timestamps
• Nested data structures for integration
• API-friendly format

CSV Format

• Spreadsheet-compatible export
• One row per requirement
• Key fields: ID, status, priority, blocking, dates
• Import into Excel/Google Sheets

Use Cases

1. Executive Dashboard

# Quick status check for leadership
python mdr_compliance_tracker.py current_status.json

2. Gap Analysis Meeting

# Detailed report for team review
python mdr_compliance_tracker.py current_status.json -v > gap_analysis_report.txt

3. System Integration

# Export for project management tools
python mdr_compliance_tracker.py current_status.json -o json -f status.json

4. Spreadsheet Analysis

# Export for detailed tracking in Excel
python mdr_compliance_tracker.py current_status.json -o csv -f requirements.csv

5. Notified Body Preparation

# Generate comprehensive compliance report
python mdr_compliance_tracker.py pre_submission.json -v -f submission_readiness.txt

Compliance Status Values

• NOT_STARTED: Requirement not yet addressed
• IN_PROGRESS: Work ongoing but not complete
• PARTIALLY_COMPLIANT: Partially meets requirements, gaps remain
• COMPLIANT: Fully compliant, documentation complete
• VERIFIED: Compliance verified by Notified Body or internal audit
• NOT_APPLICABLE: Requirement does not apply to this device

Priority Levels

• BLOCKING: Must be complete for CE marking submission
• HIGH: Critical for submission, important for approval
• MEDIUM: Important but not blocking submission
• LOW: Nice to have or future consideration

MDR Annex/Article Values

• ANNEX_I_GSPR: General Safety and Performance Requirements
• ANNEX_II_TECH_DOC: Technical Documentation (Class I, IIa, IIb)
• ANNEX_III_TECH_DOC_CLASS_III: Technical Documentation Class III
• ANNEX_XIV_CLINICAL: Clinical Evaluation and PMCF
• ARTICLE_61_CLINICAL_EVAL: Clinical Evaluation Requirements
• ARTICLE_83_92_PMS: Post-Market Surveillance
• ARTICLE_27_UDI: UDI System