EUROPEAN REGULATORS: NEW GUIDANCE ON NANOTECHNOLOGY

EU Commission Issues New Guidance on Nanotechnology in Medical Devices

Thec has published new guidance for manufacturers, regulators and Notified Bodies on how to assess potential risks posed by the use of nanotechnology in medical devices. The regulatory guidance was issued by the Commission’s Scientific Committee on Emerging and Newly Identified Health Risks and recommends assessments of devices with nanomaterials in conjunction with the ISO 10993-1:2009, which sets the standard for biological safety evaluations of medical devices.

An addition to ISO 109993 with more specific information on nanotechnology is forthcoming from ISO. Evaluations of nanotechnologies should take certain parameters into account such as chemical composition, particle size, physical form and surface chemistry, and how exposure to a device could impact on the health of a user or patient. The guidance further outlines a four-phase evaluation to assess potential risks of devices that incorporate nanotechnologies.