mdr-745-specialist

Malicious tool definition detected

Tool: SKILL.md [1/2] Description: --- name: mdr-745-specialist description: 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.

Tool: SKILL.md [2/2] Description: to each device variant 3.

Malicious tool definition detected

Tool: references/clinical-evidence-requirements.md [1/2] Description: # Clinical Evidence Requirements MDR Annex XIV clinical evaluation and post-market clinical follow-up guidance. --- ## Table of Contents - [Clinical Evidence Framework](#clinical-evidence-framework) - [Clinical Evaluation Process](#clinical-evaluation-process) - [Literature-Based Evidence](#literature-based-evidence) - [Clinical Investigation Requirements](#clinical-investigation-requirements) - [Post-Market Clinical Follow-up

Tool: references/clinical-evidence-requirements.md [2/2] Description: Identify residual risks from clinical evaluation 2.

Malicious tool definition detected

Tool: references/mdr-classification-guide.md [1/2] Description: # MDR Device Classification Guide EU MDR 2017/745 Annex VIII classification rules and decision framework.

Tool: references/mdr-classification-guide.md [2/2] Description: ``` ### Example 3: Hip Implant ``` Device: Total hip replacement prosthesis Analysis: - Invasiveness: Surgically invasive, implantable - Duration: Long-term (permanent) - System: Musculoskeletal - Rule Applied: Rule 8 (implantable, long-term) Classification: Class III Rationale: Implantable > 30 days in direct contact with bone Conformity Route: Annex IX + Annex X (full QMS + type examination) ``` ### Example 4: Diagnostic Software

Malicious tool definition detected

Tool: references/technical-documentation-templates.md [1/2] Description: # Technical Documentation Templates MDR Annex II and III technical file structure and content requirements.

Tool: references/technical-documentation-templates.md [2/2] Description: Annex III Additions ### Class III Specific Requirements Additional documentation for Class III devices: **Implant-Specific Requirements** - Implant card information - Patient information leaflet - Device tracking procedures - Explant analysis capability **Drug-Device Combination** - Drug substance specification - Drug compatibility testing - Combined product assessment - Pharmacovigilance interface --- ## Document Templates

Malicious tool definition detected

Tool: scripts/mdr_gap_analyzer.py [1/2] Description: #!/usr/bin/env python3 """ MDR Gap Analyzer - EU MDR 2017/745 Compliance Gap Assessment Tool Analyzes device classification, identifies documentation gaps, and generates compliance roadmap for EU MDR transition.

Tool: scripts/mdr_gap_analyzer.py [2/2] Description: "Required for placing device on EU market." ) return recommendations def format_text_output(result: GapAnalysisResult) -> str: """Format analysis result as text.""" lines = [ "=" * 60, "MDR 2017/745 GAP ANALYSIS REPORT", "=" * 60, f"Device: {result.device_name}", f"Class: {result.device_class}", f"Date: {result.analysis_date[:10]}", "", "-" * 60, "SUMMARY", "-" * 60, f"Total Requirements: {result.total_requirements}", f"Gaps Identified: {resul