Merging multiple IFUs into a single Femoral 3 document meant every cross-reference in the correlation tables had to hold up, since a single wrong mapping would carry forward into every reviewer who relied on it downstream.
One wrong cross-reference, many inherited errors
A technical documentation correlation table is only as reliable as its weakest cross-reference. Merging IFUs together multiplies the number of places a single mapping error can resurface.
- 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 requirement risks
An MDD-era requirement with no confirmed MDR equivalent, left unmapped in the technical file until a notified body identifies the gap, is the direct risk of merging documents without re-verifying every correlation.
What the merge delivered
Closing the identified MDD-to-MDR documentation gap moved the technical file a step closer to full MDR readiness, with the Femoral 3 IFUs now merged into one verified document.
The Real Takeaway
The technical documentation correlation tables are the backbone of an MDR technical file.
Get the cross-reference wrong once and every downstream reviewer inherits the error.