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.

Install to Claude Code

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