Open only to full-conference registrants with a badge. Collect your ticket at the Solutions Circle check-in desk at least 15 min before session start. First-come, first-served seating; standby tickets issued when full. Seats held for 3 minutes after start time.
Description MDR Article 88 is often treated as a statistical question, but in practice the real challenge is defining a proportionate and usable approach for trend reporting. What should be trended? How should thresholds and observation periods be set? And when does an increase in frequency or severity become relevant for residual risk and benefit-risk?
This Solution Circle will explore practical approaches to identifying, assessing, and documenting meaningful trends in non-serious incidents and expected undesirable side-effects. The focus will be on workable PMS methods, clear escalation criteria, and proportionate documentation that support sound vigilance decisions without turning Article 88 into an overly theoretical exercise.
