SCHEER Phthalate Guidance Updates

The European Commission has tasked its Scientific Committee on Health, Environmental, and Emerging Risks (SCHEER) with revising guidelines related to the assessment of specific phthalates in medical devices. This applies to phthalates with harmful properties such as being carcinogenic or endocrine-disrupting. Manufacturers, dealing with the requirements of General Safety and Performance Requirement (GSPR) 10.4.3 of Annex I MDR, face challenges in justifying the presence of these phthalates in their products. Phthalates are commonly used in medical equipment and electronics but have raised concerns due to environmental impact and potential harm to patients. The guidelines, as mandated by the EC, are subject to periodic reassessment every five years. The EC is currently gathering feedback from stakeholders for SCHEER’s evaluation, with detailed information on its official website.

SCHEER Guidelines