mdr-745-specialist

Provides EU MDR 2017/745 compliance guidance for medical device classification, documentation, and surveillance.

2|1|Updated Jan 29, 2026

Search Tags:#gap analysis #regulatory compliance #medical device #post-market surveillance #clinical evidence #eudamed #mdr 2017/745

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npx skills add https://github.com/bhaktofmahakal/ai-counsellor-hf --skill mdr-745-specialist-bhaktofmahakal

💬 Prompt for ChatGPT / Claude Chat▼

Please help me install this Agent Skill.
Skill: mdr-745-specialist
Source: https://github.com/bhaktofmahakal/ai-counsellor-hf/tree/main/.claude/skills/mdr-745-specialist
Command: npx skills add https://github.com/bhaktofmahakal/ai-counsellor-hf --skill mdr-745-specialist-bhaktofmahakal

SYSTEM DOCUMENTATION & REQUIREMENTS

💡 This Skill includes scripts (resource) and references (resource) and assets (resource) components.

What problem does it solve? Medical device manufacturers struggle to interpret and implement the complex EU MDR 2017/745 regulation, risking non-compliance, delayed market access, and failed Notified Body audits. ## Core Features & Use Cases - Device Classification & Conformity Assessment: Applies MDR Annex VIII rules to determine device class (I, IIa, IIb, III) and select the appropriate conformity assessment route. - Technical Documentation & Clinical Evidence: Guides preparation of Annex II/III technical files, clinical evaluation reports, and PMCF plans per Annex XIV. - Post-Market Surveillance & UDI: Supports PMS plan development, PSUR preparation, serious incident reporting, and EUDAMED/UDI registration. - Use Case: A manufacturer transitioning a Class IIb device from the legacy MDD directive uses this Skill to run a gap analysis, update the technical file, and prepare for the Notified Body audit. ## Quick Start Ask the assistant to perform an MDR gap analysis and classification assessment for your medical device, including technical documentation and clinical evidence requirements.

Frequently Asked Questions about mdr-745-specialist

High-intent search queries and answers about installing and using this skill.

FAQPage Schema

How do I classify a medical device under EU MDR 2017/745?▼

Apply the classification rules in MDR Annex VIII based on device duration, invasiveness, and body system interaction. Software devices follow MDCG 2019-11 guidance, and borderline cases should be validated with Notified Body consultation.

What technical documentation is required for MDR compliance?▼

MDR Annex II requires device identification and UDI-DI, intended purpose, labeling and instructions for use, risk management documentation, design and manufacturing information, and evidence of General Safety and Performance Requirements compliance.

When is a clinical investigation required under MDR?▼

Clinical investigations are required for Class III implantable devices per Article 61, for novel devices, and when significant changes are made. Otherwise, literature-based clinical evidence per MEDDEV 2.7/1 rev.4 may suffice.

Does MDR require post-market surveillance for all device classes?▼

Yes, MDR Chapter VII requires a PMS plan per Article 84 for all devices. Higher-risk classes also need Periodic Safety Update Reports, serious incident reporting, and trend analysis integrated with PMCF activities.

What are the limitations of literature-based clinical evidence under MDR?▼

Literature-based evidence is insufficient for novel devices, Class III implantables, or devices with significant changes. A gap analysis determines whether existing clinical data is adequate or a clinical investigation is mandatory.