•As of 1 January 2026, an important update to the Regulation (EU) 2017/745 (MDR) reinforces how manufacturers must assess hazardous substances in medical devices—especially phthalates, CMR, and endocrine-disrupting substances.
This is not a completely new obligation—but it significantly strengthens expectations around guidance, review cycles, and scientific justification.
•This is a major shift:
Manufacturers must now justify why phthalates are still necessary, not just prove they are safe.
•The same logic now extends beyond phthalates. For:CMR substances (Carcinogenic, Mutagenic, Reprotoxic) and Endocrine-disrupting chemicals.
•Contact our expert for a stronger benefit-risk justifications.