EU MDR Transition - Quality Plan & GSPR Update

Context

Reviewing the international website checklist and updating the IFU for MDR, alongside the Vista technical file check, meant building the quality plan country/product-specific from the start rather than applying one generic plan across every product line.

Primary Risks Identified

• An MDD-era requirement with no confirmed MDR equivalent, left unmapped in the technical file until a notified body identifies the gap

Testing Approach

Mapped each MDD-era requirement/document against its MDR equivalent using the technical documentation correlation tables, verified against applicable harmonized standards, and tracked action items to closure in the quality plan.

Outcome

Updated the quality plan action items and GSPR checklist for the MDR conversion, giving the team a clear path from MDD to MDR compliance.

Key Lessons

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.