mdr-745-specialist
EU MDR 2017/745 compliance specialist for medical device classification, technical documentation, clinical evidence, and post-market surveillance. Covers Annex VIII classification rules, Annex II/III technical files, Annex XIV clinical evaluation, and EUDAMED integration.
Install via CLI (Recommended)
clawhub install openclaw/skills/skills/alirezarezvani/mdr-745-specialistWhat This Skill Does
The mdr-745-specialist skill is a sophisticated compliance engine designed to streamline the navigation of the EU Medical Device Regulation (MDR 2017/745). It serves as an expert assistant for medical device manufacturers, regulatory affairs professionals, and quality assurance teams. The skill automates complex regulatory workflows, including the application of Annex VIII classification rules, the assembly of Annex II technical files, the drafting of clinical evaluation reports (CERs) under Annex XIV, and the systematic mapping of General Safety and Performance Requirements (GSPR). By integrating MDCG guidance documents, such as MDCG 2019-11 for software classification, it helps mitigate risks of non-compliance and accelerates the path to CE marking.
Installation
To install this skill, run the following command in your terminal:
clawhub install openclaw/skills/skills/alirezarezvani/mdr-745-specialist
Use Cases
- Device Classification: Rapidly determine the correct risk class (I, IIa, IIb, or III) for new hardware or AI-driven diagnostic software by providing product specifications.
- Technical Documentation Audits: Generate comprehensive GSPR checklists and verify that technical files adhere to Annex II/III structures.
- Clinical Evidence Planning: Create structured templates for Clinical Evaluation Plans (CEP) and track post-market surveillance (PMS) requirements.
- Regulatory Gap Analysis: Identify missing documentation or non-compliant labeling elements relative to current MDR standards.
Example Prompts
- "Classify a new infusion pump that uses AI to adjust dosage based on patient vitals. Apply Annex VIII rules and cite relevant MDCG guidance."
- "Generate a draft GSPR compliance matrix table for a Class IIa sterile medical device and identify the standard evidence required for each point."
- "Draft a summary for the Post-Market Surveillance plan for a Class IIb orthopedic implant, ensuring it meets the requirements of Article 83 and 84."
Tips & Limitations
This skill is intended for professional use and serves as an advisory tool. While it accurately maps regulatory logic, it does not replace the formal opinion of a Notified Body. Always ensure the output is reviewed by your Regulatory Affairs (RA) team before submitting files to authorities. Keep your device documentation updated in EUDAMED as regulatory interpretations evolve.
Metadata
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Find the right skillPaste this into your clawhub.json to enable this plugin.
{
"plugins": {
"official-alirezarezvani-mdr-745-specialist": {
"enabled": true,
"auto_update": true
}
}
}Tags(AI)
Flags: file-read, file-write
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