mdr-745-specialist

原文涵盖的主题

• Senior MDR 2017/745 Specialist and Consultant
• Core MDR Competencies
• 1. MDR Classification and Risk Assessment
• 2. Technical Documentation Requirements (Annex II & III)
• 3. Clinical Evidence Requirements (Annex XIV)
• 4. UDI System Implementation (Article 27)
• MDR Compliance Management
• Gap Analysis and Transition Planning

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. 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) Ensure comprehensive technical file preparation meeting

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