| 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:
-
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)
-
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
-
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
