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Mdr 745 Specialist

Listed
davila7·vlatest·frontend·MIT

This skill provides a specialized frontend component (MDR 745) built by davila7 for enhanced user interactions and data display.

Repository

Install on your platform

Showing Claude Code. One command installs this skill into any of the agents below.

  1. 1

    Run this in your project

    terminal
    $ npx skills add davila7/claude-code-templates --skill mdr-745-specialist -a claude-code

  2. Uses the open-source skills CLI and needs Node.js. Add -g to install it for your user instead of this project.

What we know about this skill

Publisher

davila7

Taken from the source listing. We haven't verified who controls this account.

Install target

Live repository

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scanned

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Not scanned. none of the 457 skills in the repository match this slug — it was most likely renamed or removed upstream after the registry indexed it Source recorded as davila7/claude-code-templates.
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About this skill

What it does

This skill provides expert guidance on EU MDR 2017/745 compliance, covering medical device regulation requirements, technical documentation, clinical evidence, and post-market surveillance obligations. It specializes in classification and risk assessment, helping users determine the appropriate conformity assessment route for their medical devices. The skill offers a structured framework to guide these processes, referencing relevant MDCG guidance and considering borderline cases.

When to use it

  • To determine the correct classification class (I, IIa, IIb, or III) of a medical device according to MDR Annex VIII.
  • When selecting the appropriate conformity assessment route for a medical device.
  • For assistance in preparing comprehensive technical documentation as required by Annex II and III of the MDR.
  • To understand the implications of combination devices on classification.
  • To prepare for consultation with a Notified Body regarding device classification.

Key capabilities

  • Classification Decision Framework: Applies MDR Annex VIII rules to determine device classification.
  • Risk Assessment Guidance: Provides expert guidance on risk assessment related to medical devices.
  • Conformity Assessment Route Selection: Advises on selecting the appropriate route (self-certification, Module C2, Module B+C/D, or full quality assurance).
  • Technical Documentation Structure: Outlines the structure of technical documentation required by Annex II & III.
  • MDCG Guidance Consideration: Incorporates guidance from MDCG documents like MDCG 2019-11 for software classification.

Example prompts

  • "What is the MDR classification for a device that [describe device characteristics]?"
  • "Based on this description of my medical device, what conformity assessment route should I choose?"
  • "Can you outline the required structure for technical documentation under Annex II of the MDR?"

Tips & gotchas

  • This skill provides expert guidance but does not replace the need for consultation with a Notified Body.
  • The classification process can be complex, especially for combination devices or borderline cases; careful consideration and documentation are essential.
  • Referencing the references/mdr-classification-guide.md document is crucial for understanding the rationale behind classification decisions.