Context
Completing RigidFix's technical file, alongside the MDR codes database and QMS cert database, meant mapping each MDD-era code to its confirmed MDR equivalent rather than treating the conversion as a general update.
Regulatory Affairs • EU MDR
EU MDR Transition - Technical Documentation Correlation
Duration: 12 months • Role: Regulatory Affairs Specialist
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.
MDD to MDR Mapping
Harmonized Standards Verification
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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