Amendment: DEHP in medical devices (Regulation 1907/2006)
COMCMT1R-EP1R-C2R-EPCNCADO
Updated 38mo ago
This regulation updates the rules regarding the use of bis(2-ethylhexyl) phthalate (DEHP), a chemical plasticizer, in medical devices. It aims to protect human health and the environment by limiting the presence of this substance in specific medical equipment where safer alternatives are available.
This affects medical device manufacturers and healthcare providers. It requires a transition to materials that do not contain DEHP for certain categories of medical devices to reduce patient and provider exposure to potentially harmful chemicals.