skills.rest
I-Onlabs
I-OnlabsCOMMUNITY
Explore all skills by this author →
GitHub

mdr-745-specialist

Guide EU MDR 2017/745 compliance with classification, risk assessment, and documentation planning.

3|1|Updated Dec 21, 2025
Search Tags:#compliance#regulatory#clinical-evidence#pms#mdr#udi#notified-body
One-click install
npx skills add https://github.com/I-Onlabs/claude-code-skills --skill mdr-745-specialist-i-onlabs
Or copy as Structured Prompt for Agent▼
Please help me install this Agent Skill.
Skill: mdr-745-specialist
Source: https://github.com/I-Onlabs/claude-code-skills/tree/main/mdr-745-specialist
Command: npx skills add https://github.com/I-Onlabs/claude-code-skills --skill mdr-745-specialist-i-onlabs

SYSTEM DOCUMENTATION & REQUIREMENTS

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

What problem does it solve?

Navigate EU MDR 2017/745 regulatory requirements for medical devices, enabling teams to interpret obligations, perform gap analyses, and structure technical documentation, clinical evidence plans, and post-market surveillance strategies.

Core Features & Use Cases

  • MDR classification and risk assessment guidance covering classes I–III, including software classification per MDCG guidance.
  • Annex II/III-driven technical documentation planning, clinical evidence strategy (literature reviews, clinical investigations, PMCF), and PMS integration.
  • UDI implementation and EUDAMED registration support plus Notified Body engagement strategy to streamline conformity assessment.
  • Gap analysis and transition planning for legacy devices and new submissions with NB-aligned timelines.
  • Use Case: A mid-market device team uses this skill to map MDR obligations, draft the technical file, and plan PMCF in preparation for NB submission.

Quick Start

Initiate a regulatory readiness review by performing an MDR gap analysis and drafting the initial Annex II/III outline.

Frequently Asked Questions about mdr-745-specialist

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

FAQPage Schema
How do I structure technical documentation to meet EU MDR Annex II and Annex III requirements?▼

Technical documentation for EU MDR must follow Annex II and III requirements by structuring device description, risk assessment, clinical evidence, and PMS strategies into a compliant file. This skill guides drafting the initial Annex II/III outline and mapping obligations.

What is the best way to perform an MDR gap analysis for legacy medical devices?▼

An MDR gap analysis for legacy devices identifies missing regulatory obligations and structures transition planning. This skill enables teams to assess compliance gaps, draft technical files, and align submission timelines with Notified Body expectations.

How do I classify medical devices and software under MDR risk classes I through III?▼

MDR classification assigns devices to risk classes I through III based on intended purpose and rules per MDCG guidance, including specific criteria for software. This skill provides classification guidance to determine conformity assessment pathways.

Can I use this skill to plan post-market surveillance and PMCF strategies?▼

Yes, you can use this skill to plan post-market surveillance and PMCF strategies. It integrates PMS requirements with clinical evidence planning, helping teams structure literature reviews and clinical investigations for Notified Body submissions.

Does this skill support UDI implementation and EUDAMED registration?▼

Yes, this skill supports UDI implementation and EUDAMED registration. It guides regulatory teams through UDI integration and database registration steps required to achieve full EU MDR 2017/745 compliance for medical devices.

Related Skills

Explore More Legal & Compliance Skills→
biomaps-infrabiomaps-infra

workflow-iso-13485-certification

Create ISO 13485:2016 QMS documentation and perform gap analysis.

Official
Advanced
devCharuzudevCharuzu

mdr-745-specialist

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

Community
Advanced
tapanshahtapanshah

mdr-745-specialist

Guide EU MDR 2017/745 compliance for medical device classification and documentation.

Community
Advanced
SJTU-IPADSSJTU-IPADS
7

regulatory-affairs-head

Plan medical device submissions across FDA, EU MDR, and global markets.

Official
Advanced