Context
The MDR update presentation needed to be backed by an actual mapping exercise, not a general summary of progress. Each MDD-era code required an explicit, traceable MDR equivalent before the presentation could claim the item was closed.
Regulatory Affairs • EU MDR
EU MDR Transition - Technical Documentation Correlation
Duration: 4 months • Role: Regulatory Affairs Specialist
Presenting the MDR update showed that MDD-to-MDR transition work only closes cleanly when each old MDD code/requirement is explicitly mapped to its MDR equivalent. Treating it as a general update instead of a traceable mapping exercise leaves gaps a notified body will find first.
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
Harmonized Standards
Quality Plan Tracking
Outcome
Completed the technical documentation correlation to the applicable international standards, closing an open item in the MDR technical file.
Key Lessons
MDD-to-MDR transition work only closes cleanly when each old MDD code/requirement is explicitly mapped to its MDR equivalent. Treating it as a general update instead of a traceable mapping exercise leaves gaps a notified body will find first.
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