Preparing for MDR? Don’t Overlook the Analytical Evaluation Threshold

Medical device manufacturers have a big challenge in preparing for their regulatory device submissions for 2020. In addition to the European Union’s new Medical Device Regulation (MDR) taking effect in May, the International Organization for Standardization (ISO) published the latest version of ISO 10993-18 in January 2020. These updates emphasize the criticality of chemical characterization studies and toxicological risk assessments, and a key concept in successful implementation of these activities is the analytical evaluation threshold (AET).