MDR 2017/745 Specialist
This skill provides comprehensive guidance for EU MDR 2017/745 compliance, covering device classification under Annex VIII, technical documentation per Annex II/III, clinical evaluation per Annex XIV, post-market surveillance including PSUR schedules, and EUDAMED/UDI requirements. It produces structured outputs such as classification rationales, technical file checklists, gap analyses, and compliance roadmaps.
✨ What it does
- Provides step-by-step classification workflow with rules and examples.
- Includes technical documentation structure and GSPR compliance checklist.
- Outlines clinical evidence requirements and CER structure.
- Defines PMS system components and PSUR schedules by device class.
- Details EUDAMED modules and UDI label requirements.
- Offers a gap analyzer tool for compliance assessment.
🎯 When to use it
- When classifying a medical device under MDR Annex VIII rules.
- When building or gap-checking a technical file for MDR compliance.
- When planning clinical evaluation or post-market surveillance activities.
- When preparing for notified body review or conformity assessment.
- When implementing UDI and EUDAMED registration requirements.
🚀 How to use
Trigger the skill by asking questions like 'What class is my device under MDR?' or 'Review my PSUR schedule.' Provide device details such as duration, invasiveness, body system, and whether it is active or software. The skill will guide through classification, documentation, or PMS planning. Example prompts:
Classify a surgical mesh implant under MDR.
What are the PSUR requirements for a Class IIb device?
📄 Output: The skill produces classification rationales, technical documentation checklists, gap analysis reports, and compliance roadmaps.
📦 Add this skill to Claude Code
# 1. Get the skills repo
git clone --depth 1 https://github.com/alirezarezvani/claude-skills /tmp/claude-skills
# 2. Copy this skill into your project (or ~/.claude/skills for all projects)
mkdir -p .claude/skills
cp -r /tmp/claude-skills/ra-qm-team/skills/mdr-745-specialist .claude/skills/mdr-745-specialistSkill source: ra-qm-team/skills/mdr-745-specialist/SKILL.md
⚠️ Good to know
The skill provides guidance based on MDR text but does not replace formal legal advice or notified body decisions; validation with a Notified Body is recommended.
❓ FAQ
What is the PSUR frequency for Class IIa devices?
Class IIa devices require PSUR updates when necessary, at least every 2 years.
How is software classified under MDR?
Software classification follows MDCG 2019-11, considering the information provided and condition severity, ranging from Class IIa to III.
What are the serious incident reporting timelines?
Serious public health threats must be reported within 2 days, death or serious deterioration within 10 days, and other serious incidents within 15 days.
🤖 Overview, features, install steps and FAQ were generated from the project's SKILL.md on Sep 4, 2026. Always check the original source before running commands.