Real file from a public repo · synced Aug 26, 2026
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').
Works with
Install in three steps
- 1
Download the ZIP
One file per agent, plus INSTALL.md with the exact paths below.
- 2
Claude Code: copy SKILL.md into your skills folder
.claude/skills/mdr-745-specialist/SKILL.md # this project ~/.claude/skills/mdr-745-specialist/SKILL.md # every project
- 3
Other agents: use the matching file
skill.mdc goes in Cursor’s .cursor/rules/. AGENTS.md works as GitHub Copilot instructions, a legacy .cursorrules, or a Codex / Gemini CLI instructions file.
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