Mdr 745 Specialist

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