Commentary Guidelines on the benefit-risk assessment of the presence of phthalates in certain medical devices covering phthalates which are carcinogenic, mutagenic, toxic to reproduction (CMR) or have endocrine-disrupting (ED) properties
Wim De Jong, Teresa Borges, Rodica Mariana Ion, Demosthenes Panagiotakos, Emanuela Testai, Theo Vermeire, Ulrike Bernauer, Christophe Rousselle, Stéphane Bégué, Hilde M. Kopperud, Maria Rosaria Milana, Tanja Schmidt, Roberto Bertollini, Pim de Voogt, Raquel Duarte-Davidson, Peter Hoet, Renate Kraetke, Ana Proykova, Theo Samaras, Marian Scott, Remy Slama, Marco Vighi and Sergei Zacharov | January 9th 2020
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The guidelines provide a framework to perform a BRA to justify the presence of CMR or ED phthalates in medical devices.
They also describe the evaluation of possible alternatives for these phthalates used in medical devices.
Manufacturers are encouraged to generate data that are needed for the BRA on potential alternatives to be used in medical devices.
