SCENIHR Publishes Final Opinion on Guidance on the Determination of Potential Health Effects of Nanomaterials Used in Medical Devices

 On January 13, 2015, the European Commission (EC) and its Scientific Committee on Emerging and Newly Identified Health Risks (SCENIHR) published the final opinion “Guidance on the Determination of Potential Health Effects of Nanomaterials Used in Medical Devices.”  According to the EC, the Guidance provides information on how to evaluate the risk when a nanomaterial is used in a medical device.  The EC states that the Guidance addresses the use of nanomaterials in medical devices regarding specific aspects that need to be considered in the safety evaluation of nanomaterials and it should be considered in conjunction with the International Organization for Standardization (ISO) 10993-1:2009 standard “Biological evaluation of medical devices.”  The SCENIHR Guidance highlights the need for special considerations in relation to the safety evaluation of nanomaterials, in view of the possible distinct properties, interactions, and effects that may differ from conventional forms of the same materials.  SCENIHR recommends a phased approach based on potential release and characteristics of the nanomaterials.