Scientific Committees

Public Consultation on the Determination of Potential Health Effects of Nanomaterials Used in Medical Devices

Final Opinion

‘Guidance on the Determination of Potential Health Effects of Nanomaterials Used in Medical Devices’

The opinion addresses the use of nanomaterials in medical devices and to provide information for risk assessors regarding specific aspects that need to be considered in the safety evaluation of nanomaterials.

Final opinionpdf(2 MB)

A public consultation on this opinion was opened on the website of the non-food scientific committees from 18 July 2014 to 3 October 2014. Information about the public consultation was broadly communicated to national authorities, international organisations and other stakeholders.

Eleven organisations and companies participated in the public consultation providing input to the main scientific questions (in total 110 contributions were received).

Each submission was carefully considered by the SCENIHR and the Working Group and the scientific opinion has been revised to take account of relevant comments.

The text of the comments received and the response provided by the SCENIHR is available herepdf(469 KB).