Mdr 745 Specialist

If you're building or documenting medical devices for the EU market, this gives you the compliance scaffolding for MDR 2017/745. It walks through Annex VIII classification rules with decision matrices, technical documentation structure for Annex II/III files, clinical evaluation report templates following Annex XIV, and post-market surveillance timelines including PSUR schedules and incident reporting deadlines. The UDI and EUDAMED sections cover the registration mechanics with actual checklists for label requirements. It won't write your submissions, but it maps out what goes where and when, which is half the battle when you're staring down a Notified Body review. Most useful if you already know medical device basics but need the MDR-specific requirements laid out clearly.

skills.sh installs: 124
GitHub stars: 1.1K
last updated: Aug 21, 2026

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Install

$ npx -y skills add borghei/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.

Device Classification Workflow
Technical Documentation
Clinical Evidence
Post-Market Surveillance
EUDAMED and UDI
Reference Documentation
Tools

Clarify First

Before classifying the device or analyzing gaps, settle the inputs below. When one is missing or vague and would change the result, ask about it; when it wouldn't, use a sensible default and say which one you used.

Device characteristics: duration, invasiveness, body-system contact, and whether it is active/software (drives the Annex VIII classification).
Intended purpose: the device's claimed clinical purpose (sets the applicable rule and clinical-evidence level).
Software/AI nature: whether it is software as a medical device (MDCG 2019-11) or AI/ML (changes classification and the documentation set).

SKILL.md on GitHub