mdr-745-specialist

原文涵盖的主题

• MDR 2017/745 Specialist
• Table of Contents
• Device Classification Workflow
• Classification Matrix
• Software Classification (MDCG 2019-11)
• Classification Examples
• Technical Documentation
• Technical File Structure

EU MDR compliance patterns for medical device classification, technical documentation, and clinical evidence. -- Device Classification Workflow Technical Documentation Clinical Evidence Post-Market Surveillance EUDAMED and UDI Reference Documentation Tools -- Classify device under MDR Annex VIII: 1. Identify device duration (transient, short-term, long-term) 2. Determine invasiveness level (non-invasive, body orifice, surgical) 3. Assess body system contact (CNS, cardiac, other) 4. Check if active device (energy dependent) 5. Apply classification rules 1-22 6. For software, apply MDCG 2019-11 algorithm 7. Document classification rationale 8. Validation: Classification confirmed with Notified Body | Factor | Class I | Class IIa | Class IIb | Class III | |--------|---------|-----------|-----------|-----------| | Duration | Any | Short-term | Long-term | Long-term | | Invasiveness | Non-invasive | Body orifice | Surgical | Implantable | | System | Any | Non-critical | Critical organs | CNS/cardiac | | Risk | Lowest | Low-medium | Medium-high | Highest | | Information Use | Condition Severity | Class | |-----------------|-------------------|-------| | Informs decision | Non-serious | I

这里只展示节选，请以完整原文和当前要求为准。