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EC SCENIHR releases Final Opinion on Guidance for Nanomaterials used in Medical Devices

The European Commission’s Scientific Committee on Emerging and Newly Identified Health Risks (SCENIHR) has published its final opinion on the Guidance on the Determination of Potential Health Effects of Nanomaterials Used in Medical Devices. This follows a consultation to which eleven organisations, including NIA, responded.

The Guidance is more or less the same as the preliminary version: ‘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’. As before, these phases broadly cover ‘particle release (phase 1), particle distribution and persistence (phase 2), hazard assessment (phase 3), [and] risk characterisation/risk assessment (phase 4)’. Also as before, ‘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’.

110 contributions were provided by the eleven organisations that responded to the consultation; NIA provided five of its own. With regards to these, SCENIHR states ‘each submission was carefully considered…and consequently the scientific opinion has been revised to take account of relevant comments’. Nevertheless while ‘the scientific rationale and the opinion section were clarified and strengthened’ as a result, SCENIHR noted that a number of comments could not be taken up due to discussing ‘medicinal products and/or so-called borderline products that might be considered either as a medicinal product or as a medical device’; the Committee felt that these did not correspond to the Terms of Reference and so were not considered.


Follow this link to read the full opinion, and this to read SCENIHR’s responses to the comments provided. Follow this link to read NIA’s call to Members about the consultation and the preliminary opinion.

NIA Members can learn more about the EC Regulation on Medical Devices – 2012/0266 (COD) in the Regulatory Monitoring Database.

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