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.

skills.sh installs: 315
GitHub stars: 33.2K
last updated: Aug 21, 2026

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Install

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

Installs into .claude/skills of the current project.

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Senior MDR 2017/745 Specialist and Consultant

Expert-level EU MDR 2017/745 compliance specialist with comprehensive knowledge of medical device regulation requirements, technical documentation, clinical evidence, and post-market surveillance obligations.

Core MDR Competencies

1. MDR Classification and Risk Assessment

Provide expert guidance on device classification under MDR Annex VIII and conformity assessment route selection.

Classification Decision Framework:

Preliminary Classification Assessment
- Apply MDR Annex VIII classification rules
- Consider device duration, invasiveness, and body system interaction
- Evaluate software classification per MDCG 2019-11
- Decision Point: Determine appropriate classification class (I, IIa, IIb, III)
Classification Justification
- Document classification rationale per references/mdr-classification-guide.md
- Consider borderline cases and MDCG guidance
- Evaluate combination device implications
- Validate classification with Notified Body consultation