Building the country-by-country list for Alpha-Stim's MDR transition made one thing clear: the IFU and label content couldn't just travel forward from the MDD file, it needed to be checked against the MDR GSPR list directly.
Copied forward is not re-validated
An MDD-era IFU can read as complete and still miss MDR-specific General Safety and Performance Requirements it was never written against. Carrying the content forward without a direct GSPR check leaves that gap in place.
- 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, is exactly the kind of gap a notified body identifies during review, not something that surfaces on its own beforehand.
Closing the labeling gap
Updating the IFU/label content to reflect current MDR requirements closed the labeling gap identified during the transition review, across the full list of Alpha-Stim countries covered.
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, a distinction that only shows up when someone checks.