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Mdr 745 Specialist

alirezarezvani/claude-skills

The source file appears to be empty or unavailable, so I'm working from the name and description alone. This handles MDR 745 compliance work, which is the EU medical device regulation that replaced the old MDD directives. You'd use this when documenting technical files, clinical evaluations, or risk management for medical devices sold in Europe. The regulation is notoriously detailed and the documentation requirements are strict, so having structured guidance on classification, conformity assessment routes, and required documentation could save you from expensive consultant hours. If you're building anything that touches a patient or makes a medical claim in the EU market, you're dealing with this framework whether you like it or not.

skills.sh installs
745
GitHub stars
29.5K
last updated
Aug 21, 2026
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Install

$ npx -y skills add alirezarezvani/claude-skills --skill mdr-745-specialist --agent claude-code

Installs into .claude/skills of the current project.

Files

MDR 2017/745 Specialist

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

Table of Contents

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

SKILL.md on GitHub

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Details

Repository
github.com/alirezarezvani/claude-skills
Categories
Git & Pull Requests, Documentation, Code Review & Quality, Productivity & Planning, Automation & Workflows
First seen
Jun 3, 2026

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