Directorate-General for Health and Food Safety
Content of the opinion:
The SCENIHR Opinion is intended as guidance how to evaluate the risk when a nanomaterial is used in a medical device.
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. According to the EU Recommendation for the definition of a nanomaterial (Commission Recommendation 2011/696/EU, EC 2011) any particulate substance with at least one dimension in the size range between 1 and 100 nm is considered a nanomaterial.
This Guidance provides information to assist with safety evaluation and risk assessment on the use of nanomaterials in medical devices that should be considered in conjunction with the ISO 10993-1:2009 standard. The Guidance highlights the need for special considerations in relation to the safety evaluation of nanomaterials, in view of the possible distinct properties, interactions, and/or effects that may differ from conventional forms of the same materials.
The SCENIHR recommends a phased approach for evaluating the risk of the use of nanomaterials in medical devices based on potential release and characteristics of the nanomaterials to avoid unnecessary testing. The phases cover particle release (phase 1), particle distribution and persistence (phase 2), hazard assessment (toxicological evaluations) (phase 3), risk characterisation/risk assessment (phase 4). In phase 1 an evaluation of the potential for the device to release nanoparticles either directly or due to wear of the device during use should be carried out. In phase 2 the aim is to determine the distribution of the particles released and also their persistence potential. In phase 3 the hazard is assessed using appropriate toxicity tests taking account of the exposure characteristics and potential for persistence in specific organs. This will provide input for the final risk characterisation (phase 4).
The estimated risk needs to be compared to the risk from the use of comparable devices not incorporating nanomaterials in judging the acceptability of the risk.
The SCENIHR concludes that 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.