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

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