How does this skill assist with device classification?

The skill applies the 22 rules of Annex VIII and MDCG 2019-11 software algorithms to help users determine if a device is Class I, IIa, IIb, or III based on duration, invasiveness, and risk.

What post-market requirements are covered?

It provides workflows for Post-Market Surveillance (PMS) plans, Periodic Safety Update Reports (PSUR), clinical follow-ups (PMCF), and serious incident reporting timelines.

Can it help generate technical documentation for Notified Bodies?

Yes, it provides structured templates for Annex II and III technical documentation, including the GSPR matrix, benefit-risk analysis, and design/manufacturing descriptions.

Does it support SaMD (Software as a Medical Device) specifically?

Absolutely. It includes specific guidance for Rule 11 and MDCG 2019-11 to help software developers navigate medical device classification and software-specific GSPR requirements.

EU MDR 2017/745 Specialist

Name: EU MDR 2017/745 Specialist
Author: LuodashiV5

byLuodashiV5

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학습 및 문서화

Simplifies EU MDR 2017/745 compliance for medical devices by providing expert guidance on classification, technical documentation, and clinical evaluation.

This skill serves as a specialized regulatory assistant for navigating the complex EU Medical Device Regulation (MDR) 2017/745 framework. It provides structured workflows for device classification under Annex VIII, guidance on compiling technical documentation per Annex II and III, and frameworks for clinical evaluation and post-market surveillance. Designed for RA/QM professionals and developers building medical software, it helps ensure that technical files, GSPR checklists, and clinical evidence strategies meet the rigorous standards required for Notified Body audits and EUDAMED registration.

주요 기능

01Clinical Evaluation Report (CER) and clinical evidence strategy frameworks

02Post-Market Surveillance (PMS) and PSUR scheduling guidance

03GSPR compliance matrix mapping and technical documentation templates

041 GitHub stars

05Automated Annex VIII classification logic including MDCG 2019-11 software rules

06UDI implementation and EUDAMED module registration workflows

사용 사례

01Determining the risk class for a new Software as a Medical Device (SaMD) product

02Drafting a General Safety and Performance Requirements (GSPR) checklist for a technical file

03Establishing a post-market surveillance plan for a Class IIb medical device

주요 기능

01Clinical Evaluation Report (CER) and clinical evidence strategy frameworks

02Post-Market Surveillance (PMS) and PSUR scheduling guidance

03GSPR compliance matrix mapping and technical documentation templates

041 GitHub stars

05Automated Annex VIII classification logic including MDCG 2019-11 software rules

06UDI implementation and EUDAMED module registration workflows

사용 사례

01Determining the risk class for a new Software as a Medical Device (SaMD) product

02Drafting a General Safety and Performance Requirements (GSPR) checklist for a technical file

03Establishing a post-market surveillance plan for a Class IIb medical device