eu-mdr-gspr-mapper: Скилл для соответствия требованиям безопасности

--- name: eu-mdr-gspr-mapper description: EU MDR General Safety and Performance Requirements (GSPR) mapping and compliance documentation skill allowed-tools: - Read - Write - Glob - Grep - Edit - Bash metadata: specialization: biomedical-engineering domain: science category: Regulatory Compliance skill-id: BME-SK-002 --- # EU MDR GSPR Mapper Skill ## Purpose The EU MDR GSPR Mapper Skill facilitates compliance with the European Medical Device Regulation (MDR 2017/745) by mapping General Safety and Performance Requirements and generating comprehensive compliance documentation. ## Capabilities - GSPR checklist generation by device classification - Annex I requirement mapping - Compliance evidence linkage - Gap analysis reporting - SSCP (Summary of Safety and Clinical Performance) drafting - UDI-DI assignment assistance - Technical documentation structure generation - Harmonized standards cross-reference - State of the art analysis support - Risk-benefit analysis documentation - Clinical evidence requirements mapping ## Usage Guidelines ### When to Use - Preparing EU MDR technical documentation - Conducting GSPR compliance assessments - Drafting Summary of Safety and Clinical Performance - Planning conformity assessment activities ### Prerequisites - Device classification determined - Applicable harmonized standards identified - Risk management file available - Clinical evaluation data compiled ### Best Practices - Map all applicable GSPR requirements early in development - Document evidence for each requirement systematically - Maintain traceability between requirements and evidence - Update documentation with regulatory changes ## Process Integration This skill integrates with the following processes: - EU MDR Technical Documentation - Clinical Evaluation Report Development - Post-Market Surveillance System Implementation - Design Control Process Implementation ## Dependencies - EUDAMED database integration - MDR Annex templates - Harmonized standards database - MDCG guidance documents - Notified body requirements ## Configuration ```yaml eu-mdr-gspr-mapper: device-classes: - Class I - Class IIa - Class IIb - Class III documentation-types: - technical-documentation - sscp - declaration-of-conformity annex-sections: - chapter-i-general - chapter-ii-design-manufacture - chapter-iii-information ``` ## Output Artifacts - GSPR compliance checklists - Requirement-to-evidence mapping - Gap analysis reports - SSCP drafts - Technical documentation templates - Harmonized standards matrices - Compliance status dashboards ## Quality Criteria - All applicable GSPR requirements identified - Evidence mapping is complete and traceable - Documentation meets Notified Body expectations - Gap analysis identifies actionable items - SSCP content meets MDR Article 32 requirements - UDI assignments follow MDR Annex VI