Nanotechnology is enabling the creation of a whole range of materials which have novel properties. It is likely to have a wide impact on medical devices, leading to innovative devices. At the nanoscale, changes to the structure of a material can lead to changes in chemical or physical behaviour (ie nanoparticles behave differently from bulk materials). This presents the potential for the development of novel therapies, including smaller implantable devices.
Since the government commissioned report 'Nanoscience and nanotechnologies: opportunities and uncertainties' (external link), published in June 2004 by the Royal Society (external link) and Royal Academy of Engineering (external link), there have been a number of further initiatives.
The most recent development was the launch, in March 2010, of a UK Strategy for nanotechnologies UK 'Nanotechnologies Strategy: Small Technologies, Great Opportunities' (external link), which confirms the Government commitment to the successful and safe development of this emerging and enabling technology. The MHRA was actively engaged with and contributed to the development of this report.
Some key actions included in the Strategy are:
- government Chief Scientific Advisers to review coordination of nanotechnologies research across government including research on safety issues
- a new website to keep the public informed about government work on nanotechnologies
- a new Nanotechnologies Collaboration Group to facilitate ongoing communication and collaboration between government, academia, industry and other interested parties.
Currently, the there are no regulations specific to medicines or medical devices that use nanotechnology. The suitability of existing regulations is continually assessed as the area evolves.
For medicines, the Commission on Human Medicines has in September 2006 reviewed the toxicology of healthcare nanoparticles (for more information, please see the safety information section).
The European Medicines Agency (EMA) published a reflection paper (external link) in June 2006 discussing the current thinking and the initiatives taken by the EMA in view of recent developments in relation to nanotechnology-based medicinal products. Neither of these reviews identified an immediate need for nanotechnology specific regulation. It is likely that nanotechnology-specific guidance will be created in the future, once there is enough data to allow for the creation of systematic guidance.
For medical devices, a European Medical Devices Expert Working Group has been set up on new and emerging technologies. This group is assessing the adequacy of the medical devices regulatory framework based on information presented by a specific nanotechnology task force.
The existing regulations for medical devices require manufacturers to carry out an analysis of the risks associated with a medical device, to eliminate or reduce these where feasible, and to assess the balance of risks and benefits. Although the regulations for medical devices do not differentiate between medical devices that use nanotechnologies and those that do not, the MHRA is of the view that the existing regulations for medical devices and medicines are sufficiently broad in scope to cover risks associated with nanotechnology.
For medical devices, it is normal for particular requirements underpinning the Directives to be specified by European standards or European Commission guidance. European standards are being developed on nomenclature for nanoparticles and, within the wider context of biological safety, on physicochemical characterisation.
The MHRA believes that current EU regulations for medicines and medical devices are sufficiently stringent and broad in scope to cover risks associated with nanotechnologies. The MHRA will keep nanotechnologies developments under review and will work with the European Commission, EMA and the European Medical Devices Expert Working Group to assess the relevant existing regulations with regard to nanotechnologies.
