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BioWorld - Thursday, December 25, 2025
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Home » European Commission publishes guidelines for phthalates in devices
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European Commission publishes guidelines for phthalates in devices

Oct. 17, 2019
By Nuala Moran
LONDON – As the May 2020 deadline for complying with the EU Medical Device Regulation (MDR) looms large, companies have been handed a further requirement they must meet if their products contain certain phthalate plasticizers. Phthalates are widely used to make polymers, in particular polyvinyl chloride (PVC), flexible. That allows it to be shaped into intubation tubes, catheters, blood bags, ventilator masks and other health care products. But the chemical bonds between phthalates and polymers are weak, and it is known they can leach into blood and other liquids, as well as be released into patients through mucous membranes.
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