Can it help prepare for a Notified Body audit?

It provides comprehensive pre-submission checklists for technical documentation, GSPR compliance matrices, and risk management files to ensure your submission is complete.

Does this skill cover software as a medical device (SaMD)?

Yes, it specifically includes classification logic for software using MDCG 2019-11 and covers software-specific requirements such as GSPR 17 and IEC 62304 documentation.

What post-market requirements are covered?

The skill covers PMS plan development, PSUR scheduling based on device class, and specific reporting timelines for serious incidents as required by Articles 87-92.

How does this skill help with medical device classification?

It uses a structured workflow based on Annex VIII rules and MDCG 2019-11 algorithms to help identify the correct risk class (I, IIa, IIb, or III) for your device, including rationale documentation.

MDR 2017/745 Compliance Specialist

Name: MDR 2017/745 Compliance Specialist
Author: micsapp

bymicsapp

0•

Learning & Documentation

Provides expert guidance on EU MDR 2017/745 compliance for medical device classification, technical documentation, and clinical evaluation.

The MDR 2017/745 Specialist skill empowers Claude to assist medical device developers and regulatory affairs professionals in navigating the complexities of the European Medical Device Regulation. It offers structured workflows for Annex VIII device classification, detailed frameworks for Annex II and III technical documentation, and comprehensive strategies for clinical evaluation under Annex XIV. Whether you are preparing for Notified Body audits, implementing Post-Market Surveillance (PMS) systems, or managing EUDAMED and UDI registrations, this skill provides the domain-specific logic, compliance checklists, and implementation patterns needed to ensure regulatory alignment and product safety.

Key Features

01Step-by-step device classification using Annex VIII and MDCG 2019-11 rules

02Clinical evaluation strategy and Clinical Evaluation Report (CER) structuring

03Post-Market Surveillance (PMS) and Periodic Safety Update Report (PSUR) planning

04Technical documentation frameworks following Annex II and III requirements

050 GitHub stars

06UDI implementation guidance and EUDAMED module registration workflows

Use Cases

01Preparing and auditing technical files for Notified Body submissions and GSPR compliance

02Classifying complex medical software (SaMD) or hardware devices under EU MDR rules

03Establishing a compliant Post-Market Surveillance system with automated reporting timelines

What are Skills?·How to Install

Install with 🐟 Skill.Fish

npx skillfish add micsapp/micstec-skills mdr-745-specialist

For use in Claude.ai and ChatGPT

Key Features

01Step-by-step device classification using Annex VIII and MDCG 2019-11 rules

02Clinical evaluation strategy and Clinical Evaluation Report (CER) structuring

03Post-Market Surveillance (PMS) and Periodic Safety Update Report (PSUR) planning

04Technical documentation frameworks following Annex II and III requirements

050 GitHub stars

06UDI implementation guidance and EUDAMED module registration workflows

Use Cases

01Preparing and auditing technical files for Notified Body submissions and GSPR compliance

02Classifying complex medical software (SaMD) or hardware devices under EU MDR rules

03Establishing a compliant Post-Market Surveillance system with automated reporting timelines