| Summary: |
The New and Emerging Technology Working Group, a sub-group of the Medical Devices Expert Group which advises the European Commission on medical devices, aimed in this report to consider the adequacy of the existing regulations in managing the use of nanotechnology in medical devices. Generally, the Working Group considers existing legislation suitable for dealing with medical devices using nanotechnology. The existing risk management approach of the regulations appropriately covers new risks such as nanotechnology. Nanotechnology concerns are concentrated on the potential for free nanoparticles. However, there possibly could be a specific classification rule moving nanomaterial products into Class III, which is a device class requiring case-by-case risk assessment. Although products coated in nanoparticles pose a risk of releasing free nanoparticles during use, this risk is very similar to that of traditional implants (e.g. hip replacements) which also can create particles through wear. There needs to be a post-market surveillance system to ensure that nanomaterial-containing devices are as safe as expected, and the methods by which risks will be examined under the present legislation must be developed further. |