A combined regulatory requirement review across multiple countries surfaced gaps in the MDR codes, the kind of gap that only shows up when IFU and label content is checked directly against the MDR requirements rather than carried forward from MDD-era documents.
Combined requirements can hide per-country gaps
Reviewing a regulatory requirement as one combined document across multiple countries makes it easy to miss where a specific country's MDR code was never actually mapped. The combined view has to resolve back down to each country's own gap.
- 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, is precisely what a notified body identifies if it isn't caught first.
What closing the gaps delivered
Updating the IFU/label content to reflect current MDR requirements closed the labeling gap identified during the combined multi-country transition review.
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, combined multi-country review or not.