Why traceability matrices fail in medical device compliance and how to fix them

Static traceability matrices in Word or Excel documents tend to become outdated quickly once requirements, supplier details, or risk controls change after initial submission. A medical device regulatory expert argues that three core problems drive this failure: unclear ownership, mismatched granularity across document levels, and the absence of traceability updates in change control workflows. To keep traceability functional, the author recommends adopting a linked-identifier system stored in an eQMS or PLM platform rather than standalone files. Change control processes should automatically trigger traceability reviews whenever design outputs, risk controls, or verification evidence are affected. Assigning a rotating project-phase owner for traceability and ensuring all evidence is directly linkable are also highlighted as practical, low-cost steps toward audit-ready compliance under EU MDR Annex II.