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