Public Consultation on the Preliminary Opinion on the Safety of Medical Devices containing DEHP- plasticised PVC or other plasticisers on neonates and other groups possibly at risk (2014 update)

The European Commission and the Scientific Committee on Emerging Newly Identified Health Risks have launched a public consultation on the Preliminary opinion on the safety of medical devices containing DEHP-plasticised PVC or other plasticisers on neonates and other groups possibly at risk (2014 update). The aim of the opinion is to update the previous opinion of SCENIHR and to provide information for risk assessors regarding specific aspects that need to be considered in the safety evaluation of medical devices containing DEHP. In line with the Stakeholder Dialogue Procedures (Annex IV to the Rules of Procedures of the Scientific Committees), the SCENIHR is now seeking feedback from the scientific community and stakeholders on the risk assessment related to the ‘Guidance on the Determination of Potential Health Effects of Nanomaterials Used in Medical Devices’. All interested parties are invited to submit written comments on the preliminary opinion by 30 November 2014 in view of gathering specific comments, suggestions, explanations or contributions on the scientific basis of the opinion, as well as any other scientific information regarding the questions addressed, to enable Scientific Committees to focus on issues which need to be further investigated. The electronic template provided with the documents should be used exclusively for the submission of comments, with reference made to the line and page numbers. Please note that comments submitted by email or post cannot be taken into account. Comments submitted after the deadline will not be considered. The SCENIHR will assess all comments from interested parties which are submitted in line with the above criteria and they will be taken into consideration, if found relevant. All comments submitted may be published on the Scientific Committees’ website. Please read the Privacy statement before submitting comments. A copy of the preliminary opinion is available at: Preliminary opinion.

European Commission Scientific Committees, 22 October 2014 ; ;