Converting the quality plan's action items from MDD to MDR meant treating the conversion as a traceable mapping exercise, not a general update applied across the plan.
A general update is not a mapping exercise
Updating a quality plan's language from MDD to MDR terms is easy to do generically. What actually closes the transition is mapping each specific old code to its confirmed MDR equivalent, one traceable link at a time.
- Mapping each MDD-era requirement/document against its MDR equivalent using the technical documentation correlation tables
- Verifying against applicable harmonized standards
- Tracking action items to closure in the quality plan
What an unmapped code risks
An MDD-era requirement with no confirmed MDR equivalent, left unmapped in the technical file until a notified body identifies the gap, is precisely what a general update, instead of a traceable mapping, leaves behind.
What the correlation delivered
Completing the technical documentation correlation to the applicable international standards closed an open item in the MDR technical file, converting the quality plan's action items with full traceability.
The Real Takeaway
MDD-to-MDR transition work only closes cleanly when each old MDD code 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.