Preliminary Guidelines on benefit-risk assessment of phthalates

Posted on 02.05.2019

MedTech Europe responded to a public consultation organised by the European Commission and the Scientific Committee on Health, Environmental and Emerging Risks (SCHEER). On 18 March, SCHEER published preliminary Guidelines on benefit-risk assessment of phthalates in certain medical devices. SCHEER was mandated by the European Commission to develop such Guidelines in view of new obligations that manufacturers of medical devices have to fulfil under the Medical Device Regulation. The Regulation requires that if phthalates are used above 0.1% in certain medical devices (e.g. devices or parts that are invasive and come into direct contact with patients), the use of these substances has to be justified and such justification shall be documented. The (preliminary) Guidelines provide the essential elements for the justification. MedTech Europe provided comments on the preliminary Guidelines and participated in a public hearing organised by the Commission on 4 April. SCHEER will revise the Guidelines based on comments received.

Further information about the Guidelines is available here.