Extracting label requirements for Germany and Russia in the same MDR update pass confirmed why a generic quality plan doesn't hold: two markets, two sets of label rules, one MDR transition effort trying to cover both.
Country-specific from the start, not retrofitted
A quality plan built generically and then adjusted per country, after the fact, tends to miss exactly the German and Russian requirements that don't map cleanly onto a single template. Building it country-specific from the start avoids that retrofit.
- Mapping each MDD-era requirement/document against its MDR equivalent using the technical documentation correlation tables
- Verifying against applicable harmonized standards for both German and Russian requirements
- 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 precisely the gap a notified body review across multiple product lines is positioned to find.
A clear path from MDD to MDR
Updating the quality plan action items and GSPR checklist for the MDR conversion, informed by the German and Russian label extraction, gave the team a clear path from MDD to MDR compliance across product lines.
The Real Takeaway
An MDR quality plan has to be built country/product-specific from the start.
A single generic plan doesn't survive contact with a notified body review across multiple product lines.