Regulatory Affairs Head
Structure EU MDR 2017/745 classification, conformity routes, and Annex II technical documentation for a medical device software or hardware product.
Overview
Regulatory Affairs Head is an agent skill most often used in Ship (also Build backend and Operate iterate) that outlines EU MDR 2017/745 device classification, conformity assessment routes, and technical documentation ex
Install
npx skills add https://github.com/alirezarezvani/claude-skills --skill regulatory-affairs-headWhat is this skill?
- Maps EU MDR Class I through Class III devices to self-certification vs notified-body assessment routes
- Lists Annex II technical documentation elements including risk management and clinical evidence hooks
- Ties quality management expectations to ISO 13485 and integrated design and surveillance controls
- Summarizes clinical evaluation plan requirements under Annex XIV for evidence planning
- Separates conformity pathways by annex modules (e.g., II, III, V) for class-appropriate depth
- Covers MDR device classes I, IIa, IIb, and III with distinct conformity assessment routes
- Anchors technical documentation to Annex II and clinical evidence to Annex XIV
Adoption & trust: 735 installs on skills.sh; 17.5k GitHub stars; 2/3 security scanners passed (skills.sh audits).
What problem does it solve?
You are building a medical device or SaMD and do not know which MDR class, annex route, or technical documentation blocks apply before you can lawfully ship in the EU.
Who is it for?
Health-tech founders and small teams preparing EU MDR submissions who need annex-structured guidance before engaging a notified body or RA consultant.
Skip if: General SaaS products outside medical device scope, or teams seeking legal sign-off without professional regulatory review.
When should I use this skill?
User needs EU MDR 2017/745 classification, conformity routes, technical documentation structure, ISO 13485 QMS alignment, or clinical evaluation planning for medical devices.
What do I get? / Deliverables
You get a class-aware outline of conformity pathways, Annex II documentation themes, QMS hooks, and clinical evidence planning aligned to MDR annex references for your next regulatory workstream.
- MDR class and conformity assessment route summary
- Annex II–oriented technical documentation outline with QMS and clinical evidence checkpoints
Recommended Skills
Journey fit
Spans multiple journey phases - primary shelf plus alternate fits below.
Regulatory submission readiness is shelved under Ship because conformity assessment, technical files, and notified-body pathways gate safe market release for regulated devices. Security subphase covers compliance and assurance work that must be satisfied before lawful CE-marked distribution in the EU.
Where it fits
Align backend audit trails and risk controls with Annex II documentation themes while implementing the device feature set.
Choose the correct MDR class and notified-body module before declaring conformity and releasing in the EU.
Update post-market surveillance and clinical evaluation procedures after design changes or vigilance events.
How it compares
Provides MDR submission structure and annex mapping, not a substitute for ISO 13485 implementation tooling or automated security scanning.
Common Questions / FAQ
Who is regulatory-affairs-head for?
Builders and leads working on EU-regulated medical devices—including software devices—who need MDR classification and documentation framing before certification steps.
When should I use regulatory-affairs-head?
Use it in Ship (security/compliance) when planning CE-marking routes; in Build (backend/integrations) when designing QMS-linked features; and in Operate (iterate) when updating post-market surveillance or clinical evaluation artifacts.
Is regulatory-affairs-head safe to install?
It is documentation-oriented regulatory guidance; verify source trust and audit findings on the Security Audits panel on this Prism page before relying on it for submission decisions.
SKILL.md
READMESKILL.md - Regulatory Affairs Head
# 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 ### Class IIb Devices - **Notified Body certification** under Annex III Module B + C or D - **Type examination** or **Full quality assurance** route - **Design examination** requirements - **Production surveillance** obligations ### Class III Devices - **Comprehensive Notified Body assessment** - **Type examination** + production surveillance OR - **Full quality assurance** system approach - **Design dossier** requirements per Annex II ## Key MDR Submission Requirements ### 1. Technical Documentation (Annex II) - Device description and intended purpose - Risk management documentation (ISO 14971) - Clinical evidence per Annex XIV - Post-market surveillance plan - Performance evaluation reports ### 2. Quality Management System (Annex I, Chapter II) - ISO 13485 compliant QMS - Design controls implementation - Risk management integration - Clinical evaluation procedures - Post-market surveillance system ### 3. Clinical Evidence Requirements - **Clinical evaluation plan** per Annex XIV - **Literature review** and gap analysis - **Clinical investigation** if required - **Post-market clinical follow-up** plan - **Clinical evaluation report** updating ### 4. UDI System Implementation - **UDI-DI assignment** and registration - **UDI-PI requirements** for higher risk devices - **EUDAMED registration** obligations - **Labeling compliance** with UDI requirements ## Submission Timeline Framework ### Pre-Submission Phase (6-12 months) 1. **Gap analysis** against MDR requirements 2. **Classification confirmation** with regulatory experts 3. **Notified Body selection** and preliminary discussions 4. **Clinical evidence strategy** development 5. **UDI strategy** and EUDAMED preparation ### Submission Preparation (3-6 months) 1. **Technical documentation** compilation 2. **QMS documentation** review and update 3. **Clinical evaluation** completion 4. **Risk management** file finalization 5. **Notified Body application** submission ### Review and Certification (6-18 months) 1. **Initial assessment** by Notified Body 2. **Questions and clarifications** response 3. **Audit activities** coordination 4. **Certificate issuance** and market access 5. **Post-market obligations** activation ## Critical Success Factors - **Early engagement** with chosen Notified Body - **Robust clinical evidence** strategy and execution - **Comprehensive risk management** throughout lifecycle - **Proactive post-market surveillance** system - **Regular monitoring** of regulatory updates and guidance ## Common Pitfalls to Avoid - **Insufficient clinical evidence** planning - **Late Notified Body engagement** - **Inadequate post-market surveillance** systems - **Poor documentation quality** and traceability - **Underestimating timeline** and resource requirements # FDA Submission Guide ## FDA Medical Device Classification and Pathways ### Class I Devices - **510(k) Exempt** - Most Class I devices - **General Controls** apply (21 CFR 820) - **FDA registration** required - **Device listing** mandatory ### Class II Devices - **510(k) Clearance** - Premarket notification - **General + Special Controls** apply - **Predicate device** identification required - **Substantial equivalence** demonstration ### Class III Devices - **PMA (Premarket Approval)** - Full safety and effectiveness review - **IDE (Investigational Device Exemption)** for clinical studies - **Clinical data** typically required - **Post-market surveillance** obligations ### De Novo Classification - **Novel devi