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...