Mdr 745 Specialist

If you're dealing with EU medical device regulations, this covers the full MDR 2017/745 compliance stack. It walks you through device classification using Annex VIII rules, helps structure your technical documentation for Annex II and III requirements, manages clinical evidence pathways including literature reviews and PMCF plans, and handles UDI system implementation with EUDAMED registration. The gap analysis framework is solid for mapping legacy directive compliance to current MDR requirements. It's comprehensive enough to guide you through Notified Body selection and audit prep, which is where most teams hit friction. Best for regulatory affairs teams or consultants who need structured guidance on the entire MDR lifecycle, not just spot checks.

Install to Claude Code

npx -y skills add davila7/claude-code-templates --skill mdr-745-specialist --agent claude-code