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