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Public Health (13-01-2015)

Final opinion - Guidance on the Determination of Potential Health Effects of Nanomaterials Used in Medical Devices

Today, the European Commission and its non-food Scientific Committee on Emerging and Newly Identified Health Risks (SCENIHR), have published the final opinion ‘Guidance on the Determination of Potential Health Effects of Nanomaterials Used in Medical Devices’.

The guidance provides information on how to evaluate the risk when a nanomaterial is used in a medical device. 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. These particles (nanoparticles) exhibit specific characteristics that differ from the characteristics of larger sized particles with the same chemical composition.

This Guidance addresses the use of nanomaterials in medical devices regarding specific aspects that need to be considered in the safety evaluation of nanomaterials and it should be considered in conjunction with the ISO 10993-1:2009 standard 'Biological evaluation of medical devices'. 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 effects that may differ from conventional forms of the same materials.

The SCENIHR recommends a phased approach based on potential release and characteristics of the nanomaterials.