Across the pond, a call for input to guide regulation of nano-enabled medical devices

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Seeking to develop rules to govern the use of nanomaterials in medical devices, the research arm of the European Commission is asking for input from anyone who has worked with the materials and observed problems.

The Scientific Committee on Emerging and Newly Identified Health Risks (SCENIHR) posted its call for assistance with the initiative March 27. It defines “medical devices” broadly, giving as examples carbon nanotubes in bone cements, polycrystalline nanoceramics in dental restorative materials and nanosilver used as a coating on implants and catheters. 

“Although the general risk assessment requirements applicable for materials used in medical devices and previous scientific opinions on risk assessment of nanomaterials are useful when assessing nanomaterials for medical applications, there is a need for further clarification in the risk assessment of such products,” the call for assistance reads. “Especially for medical devices there is such a need in view of the decentralised regulatory system.”

The document notes that the European Commission is currently preparing a proposal for a revision of its medical-device directives, and that the proposal might include provisions on the risk classification, the labeling and the instructions for use of medical devices containing nanomaterials. “The risk classification influences the stringency of the applicable conformity assessment procedure,” the document points out.

Deadline for input is March 2013.

SCENIHR’s move to build a framework for regulating manufacturers’ use of nanomaterials in medical devices may signal the European Commission’s desire to push the promising technology forward even as scientists continue working to make determinations on safety and environmental impact.

Meanwhile, in the U.S., some feel the FDA is proceeding too slowly on nanomedicine. Just last week a group of consumer and environmental organizations filed suit against the agency to force its hand in this area. According to the law firm representing the groups, FDA has “failed to respond within a reasonable time to their 2006 Petition requesting that the FDA regulate nanotechnology products” under its jurisdiction.

The groups filed their petition in May of that year. Three months later, FDA formed its Nanotechnology Task Force.

The European Commission is the executive body of the European Union. It’s responsible for proposing legislation, implementing decisions, upholding treaties and running the confederation’s day-to-day operations.