MedTech Europe contributes to the SCHEER public consultation on the revision of its guidelines on benefit-risk assessment of the presence of phthalates in certain medical devices

Posted on 16.05.2024

In accordance with the EU Medical Device Regulation, the Scientific Committee on Health, Environmental and Emerging Risks (SCHEER) is tasked to update its guidelines on benefit-risk assessment of the presence of phthalates in certain medical devices once every five years, and this year, the first revision is taking place. 

MedTech Europe submitted its contribution to the public consultation, which ran until 28 April 2024. MedTech Europe welcomes the draft revisions and the overall usefulness of the guidelines, as they have provided valuable support for companies’ obligations for this specific requirement under the sectoral legislation.  

As part of the submission, MedTech Europe also calls for the continued involvement of SCHEER in the future, once the European Chemicals Agency is tasked with the revision of these guidelines under the ‘One Substance, One Assessment’ proposal, in view of the expertise SCHEER has built on medical devices. 

For more information, please contact Roumiana Santos, Manager Chemicals.