On August 8, 2012, the European Commission (EC) Scientific Committee on Emerging and Newly Identified Health Risks (SCENIHR) posted a request it received from the EC for a scientific opinion on the safety of medical devices containing nanomaterials. According to the request, Notified Bodies have identified the following cases of alleged use of nanomaterials:
- Carbon nanotubes in bone cements;
- Nanopaste hydroyapatite powder for bone void filling;
- Polymer setting material with nanoparticles in dental cements;
- Polycrystalline nanoceramics in dental restorative materials;
- Nanosilver or other nanomaterials used as coatings on implants and catheters; and
- Nanosilver used as an antibacterial agent.
The EC states that, in addition, there are reports of iron-oxide nanoparticles injected into tumor cells to be heated-up by radiation or an external magnetic field, although this use has not yet been attributed clearly to the legislation on medicines or the to the legislation on medical devices.
The evaluation will take into account different categories of medical devices, including:
- Non-invasive medical devices, e.g., devices coming into contact with the intact skin; and
- Invasive devices such as woundcare materials, implantable medical devices, dental and bone fillings and cements, and injectable nanomaterials.
In the assessment, where relevant, the EC invites SCENIHR to differentiate between free, fixed, and encapsulated nanomaterials. SCENIHR invites interested parties to submit information that could assist it with the assessment. Information is due October 10, 2012. The EC states that it is currently preparing a proposal for a revision of the medical devices directives, which could include provisions on the risk classification, the labeling, and the instructions for use of medical devices containing nanomaterials. The deadline for SCENIHR’s opinion is March 2013.
SCENIHR posted on August 10, 2012, a call for experts on medical devices containing nanomaterials. To allow for a comprehensive assessment, SCENIHR encourages experts in various scientific fields related to the safety of medical devices containing nanomaterials to apply. SCENIHR states that “[e]xperience in risk assessment would be an advantage.” The deadline for submission for the call for experts is October 1, 2012.