The EU's Medical Devices Regulation (MDR) addresses requirements for using CMR and/or ED substances in Chapter II Section 10.4 of Annex I (MDR). The commission’s Scientific Committee on Health, Environmental, and Emerging Risks (SCHEER) finalized its revised phthalates benefit-risk assessment guidelines on June 17, 2024. Under the MDR, these guidelines must be updated at least every five years. SCHEER notes that phthalates are widely used as plasticizers of polymers or additives in various applications, including medical devices. "The interaction of phthalates with the polymers they are embedded is weak, so they may be released from the plastic product into the…