mdr-745-specialist

name	mdr-745-specialist
description	Manage — EU MDR 2017/745 compliance specialist for medical device classification, technical documentation, clinical evidence, and post-market surveillance. Covers Annex VIII classification
triggers	["MDR compliance","EU MDR","medical device classification","Annex VIII","technical documentation","clinical evaluation","PMCF","EUDAMED","UDI","notified body"]
executor	HYBRID
skill_id	business.ra-qm-team.mdr-745-specialist
status	ADOPTED
security	{"level":"high","pii":false,"approval_required":true}
anchors	["business","compliance","documentation"]
tier	2
input_schema	[{"name":"code_or_task","type":"string","description":"Code snippet, script, or task description to process","required":true}]
output_schema	[{"name":"result","type":"object","description":"Result from the automated action"},{"name":"status","type":"string","description":"Execution status: success | partial | failure"}]

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
• Technical Documentation
• Clinical Evidence
• Post-Market Surveillance
• EUDAMED and UDI
• Reference Documentation
• 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