Context
The first drafts of the MDR technical file needed a quality plan built for the specific countries and product lines involved, not a generic plan applied uniformly across the portfolio.
Regulatory Affairs • EU MDR
EU MDR Transition - Quality Plan & GSPR Update
Duration: 12 months • Role: Regulatory Affairs Specialist
Drafting the first version of the MDR technical file showed that an MDR quality plan has to be built country/product-specific from the start. A single generic plan doesn't survive contact with a notified body review across multiple product lines.
Primary Risks Identified
- An MDD-era requirement with no confirmed MDR equivalent, left unmapped in the technical file until a notified body identifies the gap
Testing Approach
Mapped each MDD-era requirement/document against its MDR equivalent using the technical documentation correlation tables, verified against applicable harmonized standards, and tracked action items to closure in the quality plan.
MDR Correlation Tables
GSPR Checklist
Technical File Drafting
Outcome
Updated the quality plan action items and GSPR checklist for the MDR conversion, giving the team a clear path from MDD to MDR compliance.
Key Lessons
An MDR quality plan has to be built country/product-specific from the start. A single generic plan doesn't survive contact with a notified body review across multiple product lines.
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