Babysitter eu-mdr-gspr-mapper

EU MDR General Safety and Performance Requirements (GSPR) mapping and compliance documentation skill

install

source · Clone the upstream repo

git clone https://github.com/a5c-ai/babysitter

Claude Code · Install into ~/.claude/skills/

T=$(mktemp -d) && git clone --depth=1 https://github.com/a5c-ai/babysitter "$T" && mkdir -p ~/.claude/skills && cp -r "$T/library/specializations/domains/science/biomedical-engineering/skills/eu-mdr-gspr-mapper" ~/.claude/skills/a5c-ai-babysitter-eu-mdr-gspr-mapper && rm -rf "$T"

manifest: library/specializations/domains/science/biomedical-engineering/skills/eu-mdr-gspr-mapper/SKILL.md

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