The European Commission’s Scientific Committee on Health, Environmental and Emerging Risks (SCHEER) has published Guidelines concerning the use of phthalates in medical devices.
The Guidelines concern the benefit-risk assessment of the presence of phthalates in certain medical devices covering phthalates which are carcinogenic, mutagenic and toxic to reproduction (CMR) or have endocrine-disrupting (ED) properties.
The Guidelines have been drafted and adopted in light of the EU Medical Devices Regulation (MDR) which will be applicable on 26 May 2020 and are intended to be used by manufacturers, notified bodies and competent authorities.