EU MDR Transition - MDD to MDR Gap Closure

Context

An MDD-era requirement had no confirmed MDR equivalent recorded in the technical file. Closing the gap meant working through the Table 2 and Table 3 correlation tables to establish a defensible cross-reference before a notified body could flag it.

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

Closed the identified MDD-to-MDR documentation gap, moving the technical file a step closer to full MDR readiness.

Key Lessons

The technical documentation correlation tables (Table 2/3-style mappings) are the backbone of an MDR technical file - get the cross-reference wrong once and every downstream reviewer inherits the error.