eu-mdr-gspr-mapper

# 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-Mar...