mdr-745-specialist-ovachiever

name	mdr-745-specialist-ovachiever
title	Senior MDR 2017/745 Specialist and Consultant
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.
author	ovachiever
author_url	https://github.com/ovachiever/droid-tings/tree/master/skills/mdr-745-specialist
license	MIT
version	0.1.0
execution_mode	open
jurisdiction	eu
practice	life-sciences
language	en

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