How does this skill help with MDR device classification?

It applies MDR Annex VIII classification rules and MDCG guidance to help determine the correct device class (I, IIa, IIb, III) and provides documented justifications for those decisions.

How does it handle post-market surveillance requirements?

It helps establish robust PMS systems per Article 84, providing frameworks for PMS plans, Periodic Safety Update Reports (PSUR), and field safety corrective actions.

Does it support UDI and EUDAMED registration?

The skill offers implementation workflows for UDI strategy development, UDI-DI assignment, and registration requirements for actors and devices within EUDAMED.

Can it help draft technical files for Notified Body review?

Yes, it provides structured templates and guidance for Annex II and Annex III technical documentation, including General Safety and Performance Requirements (GSPR) and risk management files.

Is it useful for clinical evaluation strategies?

Absolutely. It assists with clinical evaluation pathway selection, literature-based evidence appraisal per MEDDEV 2.7/1 rev.4, and PMCF plan development.

EU MDR 2017/745 Compliance Specialist

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

byBbgnsurfTech

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학습 및 문서화

Provides expert guidance and documentation support for medical device manufacturers navigating EU MDR 2017/745 regulatory requirements.

소개

The mdr-745-specialist skill acts as a comprehensive consultant for medical device regulatory affairs, helping teams manage the complexities of the European Union Medical Device Regulation (MDR 2017/745). It offers deep expertise in device classification, technical file preparation per Annex II and III, clinical evidence strategy per Annex XIV, and post-market surveillance implementation. This skill is indispensable for Quality Management and Regulatory Affairs (RA/QM) teams needing to perform systematic gap analyses, draft conformity assessments, or prepare for Notified Body audits, ensuring medical devices maintain compliance and market access in the EU.

주요 기능

3 GitHub stars
Post-market surveillance (PMS) and Periodic Safety Update Report (PSUR) frameworks
Automated MDR compliance gap assessment and transition roadmap development
Clinical evidence strategy and Clinical Evaluation Report (CER) guidance
Technical documentation structuring for Annex II and III technical files
UDI system implementation and EUDAMED registration support

사용 사례

Drafting and organizing technical documentation for new Class IIa, IIb, or III device submissions
Transitioning legacy medical devices from MDD to full MDR 2017/745 compliance
Designing a Post-Market Clinical Follow-up (PMCF) plan and evaluation report for high-risk devices

소개

주요 기능

3 GitHub stars
Post-market surveillance (PMS) and Periodic Safety Update Report (PSUR) frameworks
Automated MDR compliance gap assessment and transition roadmap development
Clinical evidence strategy and Clinical Evaluation Report (CER) guidance
Technical documentation structuring for Annex II and III technical files
UDI system implementation and EUDAMED registration support

사용 사례

Drafting and organizing technical documentation for new Class IIa, IIb, or III device submissions
Transitioning legacy medical devices from MDD to full MDR 2017/745 compliance
Designing a Post-Market Clinical Follow-up (PMCF) plan and evaluation report for high-risk devices