Can it generate a full Technical File for Notified Body submission?

It provides the structured framework, GSPR compliance checklists, and Annex II/III content requirements necessary to compile a submission-ready technical file.

Does this skill support Software as a Medical Device (SaMD)?

Yes, it specifically includes the MDCG 2019-11 software classification algorithm to help determine if your code qualifies as a medical device and its subsequent risk class.

Is the skill updated with the 2023/607 transition extensions?

Yes, the skill includes the latest transition timelines and conditions for legacy devices extending their validity under the amended MDR regulations.

How does it handle clinical evidence requirements?

The skill outlines clinical evaluation strategies, including literature search methodology, equivalence assessment, and Clinical Evaluation Report (CER) structures per Annex XIV.

EU MDR 2017/745 Compliance Specialist

Name: EU MDR 2017/745 Compliance Specialist
Author: borghei

byborghei

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Learning & Documentation

Guides medical device classification, technical documentation, and clinical evidence strategies to ensure EU MDR 2017/745 regulatory compliance.

The MDR 745 Specialist skill is a comprehensive regulatory companion designed to navigate the complexities of the European Medical Device Regulation. It provides expert logic for device classification under Annex VIII and MDCG 2019-11 (for software), assists in the creation of Annex II/III technical files, and streamlines clinical evaluation reports (CER). By integrating post-market surveillance (PMS) workflows, EUDAMED requirements, and GSPR checklists, this skill helps engineering and regulatory teams move from development to market while maintaining rigorous compliance standards and minimizing Notified Body friction.

Key Features

01Automated Annex VIII and MDCG 2019-11 software classification logic

02EUDAMED actor registration and UDI implementation guidance

03Clinical Evaluation Report (CER) and PMCF strategy frameworks

04Post-Market Surveillance (PMS) and vigilance reporting schedules

05GSPR compliance matrix generation and technical file structuring

0650 GitHub stars

Use Cases

01Classifying AI-driven diagnostic software to determine the correct conformity assessment route

02Drafting technical documentation templates for Class IIa and IIb medical devices

03Generating a comprehensive gap analysis for transitioning legacy MDD devices to MDR compliance

What are Skills?·How to Install

Install with 🐟 Skill.Fish

npx skillfish add borghei/claude-skills mdr-745-specialist

For use in Claude.ai and ChatGPT

Download Skill