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mdr-745-specialist

Guide EU MDR compliance for device classification, technical documentation, and EUDAMED integration.

Updated Apr 16, 2026
Search Tags:#risk-management#conformity#gspr#mdr#clinical-evaluation#eudamed#udi
One-click install
npx skills add https://github.com/devCharuzu/philfida-taskmanage --skill mdr-745-specialist-devcharuzu
Or copy as Structured Prompt for Agent▼
Please help me install this Agent Skill.
Skill: mdr-745-specialist
Source: https://github.com/devCharuzu/philfida-taskmanage/tree/main/.windsurf/skills/mdr-745-specialist
Command: npx skills add https://github.com/devCharuzu/philfida-taskmanage --skill mdr-745-specialist-devcharuzu

SYSTEM DOCUMENTATION & REQUIREMENTS

💡 This Skill includes scripts (resource) and references (resource) components.

What problem does it solve?

MDR compliance requires integrating complex classification rules, technical documentation, clinical evidence, and PMS activities with consistent EUDAMED integration. This skill provides a comprehensive framework and playbook to navigate MDR obligations end-to-end.

Core Features & Use Cases

  • Device classification guidance across Annex VIII with MDCG references.
  • Technical documentation roadmap covering Annex II/III files, GSPR matrix, and risk management linkage.
  • Clinical evidence strategy for Annex XIV CER and PMCF planning.
  • PMS planning and EUDAMED integration guidance for regulatory submission readiness.
  • Use Case: A medical device company preparing for Notified Body engagement and CE marking.

Quick Start

Outline a compliant MDR classification and a high-level clinical evaluation plan for a Class IIa device.

Frequently Asked Questions about mdr-745-specialist

High-intent search queries and answers about installing and using this skill.

FAQPage Schema
How do I classify a medical device under EU MDR Annex VIII rules?▼

EU MDR device classification under Annex VIII requires applying MDCG classification rules to determine risk class. This skill guides classification logic with MDCG references to define your device's regulatory scope and conformity pathway.

What should be included in MDR technical documentation for CE marking?▼

MDR technical documentation must cover Annex II/III files, a GSPR conformity matrix, and risk management linkage. This skill provides a roadmap to structure these documents for Notified Body submission readiness.

How do I create a clinical evaluation plan for MDR compliance?▼

MDR clinical evaluation requires an Annex XIV CER and PMCF planning strategy. This skill outlines clinical evidence requirements to build a compliant clinical evaluation report for your device.

How do I prepare EUDAMED registration data for a medical device?▼

EUDAMED registration readiness requires compiling UDI data and PMS planning documents. This skill guides EUDAMED integration to ensure regulatory submission data aligns with MDR obligations.

Can I use this framework for a Class IIa medical device CE marking workflow?▼

Yes, this skill supports a risk-based MDR workflow for manufacturers seeking CE marking, including Class IIa devices. It outlines classification, technical files, and clinical evaluation plans for Notified Body engagement.

Why does MDR compliance require linking risk management to GSPR conformity?▼

MDR compliance requires linking risk management to the GSPR matrix because conformity depends on demonstrated risk control. This skill maps GSPR checklist items to risk management outputs for technical documentation alignment.

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