Nanotechnological medical devices and nanopharmaceuticals: the European regulatory framework and research needs

The European regulatory framework is examined in relation to nanotechnology based medical devices and medicinal products. Medical applications of nanotechnology will have to comply with the requirement for a high level of public health, safety, consumer, and environmental protection. An evaluation of the possible health or environmental risks of nanoparticles must therefore be carried out and it is important to ensure that particle size and chemistry are taken into account when investigating possible adverse effects. Further research is needed on the toxicological and ecotoxicological properties of nanoparticles, their uptake in the body, accumulation in tissues and organs, transport characteristics, exposure and dose-response data, and their distribution and persistence in the environment. The existing regulations appear adequate to manage the risks of nanotechnology at its current stage of development but continuous review of the regulatory regime will be needed to determine whether it is sufficient to protect human health and the environment. Modification of the legislation may prove necessary as new scientific evidence emerges regarding the effects of nanoparticles on living organisms and in the ecosystems.