Incorporating Developmental & Reproductive Toxicity (DART) In Medical Device Toxicological Risk Assessments (TRAs)

By Kimberly Ehman, PhD, DABT, Eurofins Medical Device Services

The revision of ISO 10993-3 signals a significant shift in medical device safety, moving away from traditional animal testing of extracts toward a more robust framework of chemical characterization and toxicological risk assessment (TRA). This update places a spotlight on developmental and reproductive toxicity (DART) and genotoxicity, emphasizing that even devices with indirect contact must be scrutinized for their impact on reproductive health and fetal development.

Effective assessments now require a deep understanding of OECD study designs—such as OECD 443 and 414—to accurately select points of departure and apply relevant uncertainty factors. By screening extractable compounds against CMR, endocrine disruptor, and SVHC lists, risk assessors can identify potential hazards to reproductive-aged adults, pregnant women, and neonates. This systematic approach ensures that complex biological endpoints are addressed with precision, aligning device development with evolving regulatory expectations. Explore the full technical summary to master these updated methodologies for your next submission.