Finishing MDR-CE-03 meant enlisting exactly which points were missing before uploading the essential documents, rather than assuming the MDD-era IFU content already covered them.
Enlisting gaps before closing them
Uploading essential documents without first enlisting the missing points risks uploading an incomplete set with confidence. Naming the gaps explicitly is what makes the closure real rather than assumed.
- Mapping each MDD-era requirement/document against its MDR equivalent using the technical documentation correlation tables
- Verifying against applicable harmonized standards
- Enlisting the missing points and uploading the essential documents to close them
What an unmapped point risks
An MDD-era requirement with no confirmed MDR equivalent, left unmapped in the technical file until a notified body identifies the gap, is exactly what enlisting the missing points before upload is meant to catch first.
Closing the labeling gap
Updating the IFU/label content to reflect current MDR requirements closed the labeling gap identified during the transition review, with MDR-CE-03 completed and its essential documents uploaded.
The Real Takeaway
IFU and label content has to be re-validated against the MDR General Safety and Performance Requirements directly.
Not just copied forward from the MDD-era documents, which is exactly what enlisting the missing points before upload prevents.