mdr-745-specialist

# MDR 2017/745 Specialist

EU MDR compliance patterns for medical device classification, technical documentation, and clinical evidence.

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## 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)

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## 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 |
|-----------------|-------------------|-------|
| Informs decision | Non-serious | IIa |
| Informs decision | Serious | IIb |
| Drives/treats | Critical | III |

### Classification Examples

**Example 1: Absorbable Surgical Suture**
- Rule 8 (implantable, long-term)
- Duration: > 30 days (absorbed)
- Contact: General tissue
- Classification: **Class IIb**

**Example 2: AI Diagnostic Software**
- Rule 11 + MDCG 2019-11
- Function: Diagnoses serious condition
- Classification: **Class IIb**

**Example 3: Cardiac Pacemaker**
-...