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December 30, 2015

The Netherlands Publishes Report on Nanotechnologies in Medical Devices

Lynn L. Bergeson Carla N. Hutton

The Netherlands National Institute for Public Health and the Environment (RIVM) posted on December 17, 2015, a report entitled Nanotechnologies in medical devices.  RIVM conducted an investigation to provide insights into and an overview of the field of medical devices using nanotechnologies for products already on the market and for those expected within five years.  According to the report, knowledge is evolving on the safety evaluation of nanomaterials in general, and thus also when used in medical devices.  The report states that current state-of-the-art guidance provides a “suitable base” for assessing the risk of nanomedical devices.  The report states:  “Nanomaterials exhibit specific characteristics that may or may not lead to toxic effects.  As for all medical products, risk assessment of nanomedical products needs to be performed on a case-by-case basis.  The potential for release, leading to a higher or lower exposure to nanomaterials, is considered the most important feature driving the extent of the risk assessment to be performed.”