Table 2 and Table 3 exist to correlate technical documentation against international standards and General Safety and Performance Requirements, and building them surfaced exactly where IFU and label content still traced back to MDD-era assumptions.
Correlation tables expose copied-forward content
Populating a correlation table forces every referenced requirement to be checked directly. Content that was copied forward from MDD-era documents without re-validation shows up immediately as an unsupported or missing correlation.
- 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 what these correlation tables are designed to catch before a notified body does.
What the tables delivered
Updating the IFU/label content to reflect current MDR requirements closed the labeling gap identified during the transition review, once Table 2 and Table 3 made the gap visible.
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.