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# EU MDR 2017/745 Submission Guide ## MDR Classification and Conformity Assessment Routes ### Class I Devices - **Self-certification** under Annex II - **Technical documentation** requirements per Annex II - **Declaration of Conformity** mandatory - **UDI registration** required ### Class IIa Devices - **Notified Body involvement** for Annex III Module C2 + Annex V - **Quality management system** assessment - **Technical documentation** review - **Ongoing surveillance** requirements ### Clas
How to Use
Recommended: Install to project (local)
mkdir -p .claude/skills
curl -o .claude/skills/eu-mdr-submission-guide.md \
https://raw.githubusercontent.com/alirezarezvani/claude-skills/main/ra-qm-team/regulatory-affairs-head/references/eu-mdr-submission-guide.mdSkill is scoped to this project only. Add .claude/skills/ to your .gitignoreif you don't want to commit it.
Alternative: Clone full repo
git clone https://github.com/alirezarezvani/claude-skillsThen reference at ra-qm-team/regulatory-affairs-head/references/eu-mdr-submission-guide.md
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