EU Guidance on the use of nanomaterial in medical devices

This Guidance addresses the use of nanomaterials in medical devices and provides information for risk assessors regarding specific aspects that need to be considered in the safety evaluation of nanomaterials. The use of nanomaterials in medical devices poses a challenge for the safety evaluation and risk assessment of these medical devices as the specific character of the nanomaterial used should be taken into consideration.
The potential risk from the use of nanomaterials in medical devices is mainly associated with the possibility for release of free nanoparticles from the device and the duration of exposure (Website European Commission, 6 January 2015).
Click here to download the Guidance on the Determination of Potential Health Effects of Nanomaterials Used in Medical Devices (1.88 MB).

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