aibot88 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