The European Commission is urging that medical devices containing nanomaterials be reclassified as Class III devices and subject to the “most severe conformity assessment,” due to risk of particles being released into the human body. Commission recommendations for new labeling requirements for devices containing fullerenes, graphene flakes and single-wall carbon nanotubes are included in a major overhaul of EU device regulations. The proposal was adopted by the commission Sept. 26.
Devices & Diagnostics Letter