EU MDR Transition - IFU & Label Update

Context

Updating the IFUs for Healix Advanced and RigidFix, alongside their classification update, meant re-validating the IFU and label content directly against the MDR General Safety and Performance Requirements rather than copying it forward from the MDD-era documents.

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 IFU/label content to reflect current MDR requirements, closing the labeling gap identified during the transition review.

Key Lessons

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.