EU Panel tasked with risk assessment of medical devices containing nanomaterials

摘要

The European Commission has requested SCENIHR, its Scientific Committee on Emerging and Newly-Identified Health Risks, to carry out a risk assessment of medical devices containing nanomaterials'.The committee has until March 201 3 to report back on the matter The commission may use SCENIHR's opinion to propose new provisions on the risk classification, labelling and instructions-for-use of such products.These provisions would likely be proposed under ongoing efforts to revise the EU medical devices directives. Although the general risk assessment requirements applicable for materials used in medical devices and previous SCENIHR scientific opinions on risk assessment of nanomaterials are useful when assessing nanomaterials for medical applications2, the commission believes there is a need for further clarification in the risk assessment of such products.The commission wants to ensure that in case of medical devices, the risk assessors - be it the manufacturer; the notified body or the national competent authority - are aware of the specific characteristics of nanomaterials to be able to carry out the risk assessment.Notified bodies have reported on the use of nanomaterials in some specific medical devices.These include: 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.