mdr-745-specialistlisted

# MDR 2017/745 Specialist EU MDR compliance patterns for medical device classification, technical documentation, and clinical evidence. --- ## Table of Contents - [Device Classification Workflow](#device-classification-workflow) - [Technical Documentation](#technical-documentation) - [Clinical Evidence](#clinical-evidence) - [Post-Market Surveillance](#post-market-surveillance) - [EUDAMED and UDI](#eudamed-and-udi) - [Reference Documentation](#reference-documentation) - [Tools](#tools) --- ## Device Classification Workflow 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 ### Classification Matrix | 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 | ### Software Classification (MDCG 2019-11) | Information Use | Condition Severity | Class | |-----------------|-----------