mdr-745-specialist
EU MDR 2017/745 compliance specialist for medical device classification, technical documentation, clinical evidence, and post-market surveillance. Covers Annex VIII classification rules, Annex II/III technical files, Annex XIV clinical evaluation, Art. 86 PSUR schedules, and EUDAMED integration. Use when classifying a medical device under MDR, building or gap-checking a technical file, planning clinical evaluation or PMS/PSUR cadence, or preparing for notified body review (e.g., 'what class is my device under MDR', 'review my PSUR schedule').
Profile →npx skills add alirezarezvani/claude-skills --skill mdr-745-specialist --agent claude-code
Same command for any agent — swap --agent for codex, cursor, copilot.
Weekly change comes from our own snapshots, not the repository page — it measures attention, not adoption.
# 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-inva
- Table of Contents
- Device Classification Workflow
- Classification Matrix
- Software Classification (MDCG 2019-11)
- Classification Examples
- Technical Documentation
- Technical File Structure
- GSPR Compliance Checklist
- Conformity Assessment Routes
- Clinical Evidence
- Evidence Requirements by Class
- Clinical Evaluation Report Structure
- Qualified Evaluator Requirements
- Post-Market Surveillance
Quick gap analysis python scripts/mdr_gap_analyzer.py --device "Device Name" --class IIa JSON output for integration python scripts/mdr_gap_analyzer.py --device "Device Name" --class III --output json Interactive assessment python scripts/mdr_gap_analyzer.py --interactive
What does the mdr-745-specialist skill do?
EU MDR 2017/745 compliance specialist for medical device classification, technical documentation, clinical evidence, and post-market surveillance. Covers Annex VIII classification rules, Annex II/III technical files, Annex XIV clinical evaluation, Art. 86 PSUR schedules, and EUDAMED integration. Use when classifying a medical device under MDR, building or gap-checking a technical file, planning clinical evaluation or PMS/PSUR cadence, or preparing for notified body review (e.g., 'what class is my device under MDR', 'review my PSUR schedule').
How do I install it?
Run `npx skills add alirezarezvani/claude-skills --skill mdr-745-specialist --agent claude-code` — it drops the skill into your project so the agent can pick it up. Swap the --agent value for codex, cursor or copilot if you use one of those.
Where does this skill come from?
From alirezarezvani/claude-skills, a repository with 23,791 stars. We read it straight from the repository tree rather than a submitted listing, so what you see here is what is actually published.
Is a popular skill a good skill?
Not necessarily. Stars measure attention, not adoption — a repository can trend for a week and be abandoned. That is why we show the weekly change from our own snapshots next to the total, instead of a single flattering number.