MDR 2017/745 Specialist
Skill Verified ActiveEU 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.
To guide users through the complex EU MDR 2017/745 regulations for medical devices, ensuring compliance with classification, documentation, and surveillance requirements.
Features
- Medical device classification according to Annex VIII
- Guidance on technical documentation (Annex II/III)
- Clinical evidence requirements (Annex XIV)
- Post-market surveillance (PMS) processes
- EUDAMED and UDI system integration
- MDR Gap Analyzer tool for compliance assessment
Use Cases
- Classifying a new medical device under EU MDR.
- Preparing technical documentation for a medical device.
- Developing a clinical evaluation report (CER).
- Establishing a post-market surveillance system.
- Assessing compliance gaps against MDR requirements.
Non-Goals
- Providing legal advice or acting as a substitute for regulatory consultants.
- Performing actual device testing or certification.
- Covering regulatory frameworks outside of EU MDR 2017/745.
Workflow
- Understand MDR classification rules
- Prepare technical documentation
- Gather clinical evidence
- Implement post-market surveillance
- Utilize the Gap Analyzer tool for assessment
Practices
- Regulatory Compliance
- Documentation Management
- Risk Management
- Clinical Evaluation
Prerequisites
- Python 3 installed for the analysis tool
Versioning
- info:Release ManagementThe project does not have a formal versioning scheme like semver in its SKILL.md frontmatter or git tags, and install instructions reference 'main'. However, the script is standalone and unlikely to have breaking changes.
Installation
First, add the marketplace
/plugin marketplace add alirezarezvani/claude-skills/plugin install ra-qm-team@claude-code-skillsQuality Score
VerifiedTrust Signals
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