mdr-745-specialist

EU MDR compliance patterns for medical device classification, technical documentation, and clinical evidence. Classify device under MDR Annex VIII: Example 1: Absorbable Surgical Suture Example 2: AI Diagnostic Software Example 3: Cardiac Pacemaker Prepare technical file per Annex II and III: Develop clinical evidence strategy per Annex XIV: Establish PMS system per Chapter VII: Implement UDI system per Article 27: Required elements per Article 13: references/mdr-classification-guide.md contains: references/clinical-evidence-requirements.md contains: references/technical-documentation-templates.md contains: Analyzes device against MDR requirements, identifies compliance gaps, generates prioritized recommendations. Output includes: - Device Classification Workflow - Technical Documentation - Clinical Evidence - Post-Market Surveillance - EUDAMED and UDI - Reference Documentation - Tools - Identify device duration (transient, short-term, long-term) - Determine invasiveness level (non-invasive, body orifice, surgical) - Assess body system contact (CNS, cardiac, other) - Check if active device (energy dependent) - Apply classification rules 1-22 - For software, apply MDCG 2019-11 algorithm - Document classification rationale - Validation: Classification confirmed with Notified Body - Rule 8 (implantable, long-term) - Duration: > 30 days (absorbed) - Contact: General tissue -...