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NIA responds to EC Call for Information on Safety of Medical Devices containing Nanomaterials

The Nanotechnology Industries Association (NIA) has responded to a request for information and expert input required for an investigation into the safety of nanomaterials in medical devices. The response was made following a period of consultation it had held with its members. The call was issued by the European Commission's (EC) Scientific Committee on Emerging and Newly Identified Health Risks (SCENIHR).

Comments from the NIA focus on the difficulty of using the recommended EU definition of nanomaterials. Particularly, the argument is made that 'practically all solid particulates contained in medical devices will be nanomaterial according to this definition', including those generated by 'abrasion and other mechanical forces'. The response also highlights that the term 'unbound' is not specified by the recent regulatory proposal for medical devices. The proposal's limitation to 'unbound' particles means that 'every release of such a particle from the medical device would lead to the application of the rule'. This is considered 'not helpful' as 'form a scientific standpoint, the complete absence of release cannot be demonstrated'.

The NIA has also asked SCENIHR to consider materials it has supplied on nanotoxicology and the toxicology of nanosilver for medical application and (nano-)silver in medical devices, as well as review articles. The association would also 'welcome a public consultation of a draft of the opinion, [so as] to allow an opportunity to provide comments on the draft before its final adoption by SCENIHR'.

 

Follow this link to view the NIA's response, and follow this link to read the NIA's reporting of the call for information and this link to read the NIA's reporting of the EC labeling proposal for medical devices.

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