Individual skill

mdr-745-specialist

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.

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# 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