On Monday 9 September, the European Commission published guidelines on the benefit-risk assessment of the presence of phthalates in certain medical devices. These guidelines are based on the preliminary opinion of the Scientific Committee on Health, Environmental and Emerging Risks (SCHEER) and the subsequent public consultation in spring 2019.
The document focuses more specifically on the benefit-risk assessment (BRA) of the presence in medical devices of phthalates that have one or more of the following properties: carcinogenic, mutagenic, toxic to reproduction (CMR) or endocrine disrupting (ED).
As a reminder, the Medical Device Regulation (Regulation 2017/745) authorises, when appropriate justification can be provided, the use of substances with known or suspected adverse effects (CMR 1A/1B) and/or endocrine disrupting substances in medical devices at a concentration above 0.1% by weight fraction (w/w).
The guidelines therefore describe the methodology to be used to carry out such a risk-benefit assessment. They also describe the evaluation of possible alternatives for these phthalates used in medical devices. They are addressed to relevant stakeholders: for example, medical device manufacturers, notified bodies and regulatory bodies. To consult the guidelines: http://bit.ly/2lJKWLu (Original version in French by Sophie Petitjean)