Medicines, medical devices, and their combinations are one of the most important areas of application of nanotechnology. Innovations made possible by nanotechnology are expected to have a far-reaching impact on healthcare in the future. This focuses on an improved diagnosis, treatment, and monitoring of diseases. RIVM monitors and reports (newsletter) on new developments in this area for a broad public, and performs research into the most effective method for assessing the benefits and risks of nanomedical products. RIVM also collaborates with other organisations in this area.

Advantages of nanomedicines

Nanomedicines are made of materials that work at the nanometre scale. The active ingredient or the material used to package this ingredient can be composed of nanoparticles. The packaging may also have very tiny ‘pores’ at the nanometre scale through which the active ingredient is dosed in a controlled fashion. The enormous advantage of nanomedicines is that they are designed to reach the targeted site in the body more precisely and effectively, thereby reducing side-effects. They can be designed in such a way as to ensure that they dissolve more easily or are able to reach sites that are difficult to access. For example, they can then pass the blood-brain barrier in order to treat brain conditions. Most nanomedicines are used to treat cancer or infectious diseases.

Safety of nanomedicines

Nanomedicines are being used in the healthcare sector and comply with the requirements that apply to medicines. They have also been tested for their effectiveness and safety. The existing regulations that apply to medicines are also suitable for dealing with the innovative properties of nanomedicines. The European Medicines Agency (EMA) views nanomedicines as an emerging therapy. It has published a number of ‘discussion documents’ on various types of nanomedicines to assist medicines manufacturers in collecting relevant data during their product development phase. The Medicines Evaluation Board (MEB) evaluates medicines in the Netherlands for their effectiveness, safety, and quality.

Advantages of nanomedical devices

Medical devices based on nanotechnology are also available. One of the most common applications of nanotechnology in medical devices involves applying nanocoatings on implants such as stents or hip implants. The aim here is to achieve better integration with the surrounding tissue and to reduce the risk of rejection. Another group of nanoapplications focuses on the simulation of structures that are present in the human body. For example, this has resulted in the development of bone or tooth filling materials with optimum characteristics. Free nanoparticles that can be heated up after being administered are being developed to treat tumours. In the case of in vitro diagnostic devices, nanotechnology is combined with ‘lab-on-a-chip’ technologies, for example in order to enable measuring markers or indicators of disease in blood very accurately.

Safety of nanomedical devices

A so-called risk management strategy is required in order to be able to market medical devices. This means that all potential risks associated with a product, including any risks associated with nanomaterials, must be evaluated and reduced insofar as possible. In doing so, the aim is to achieve a good balance between the benefits and the risks of a product. In 2017, new regulations were published for medical devices in which provisions were also included regarding nanomaterials. These regulations specify that, in designing and manufacturing medical devices, the risks associated with the size and the properties of particles that can end up inside the body of a patient, and in particular nanomaterials, must be limited insofar as possible. In addition, there is a special classification rule for products containing nanomaterials, as a result of which such products are controlled more stringently, depending on the potential internal exposure to nanomaterials caused by such a product.

The European Commission working group ’New & Emerging Technologies’ has the topic of nanomaterials in medical devices as a standard item on its agenda. In addition, one of the scientific committees of the European Commission has written a scientific opinion on this topic. This describes how an assessment can be performed on the potential risks of nanomaterials in medical devices. In 2017, the International Organisation for Standardisation (ISO) published a Technical Report on the biological evaluation of medical devices made with nanomaterials. This report describes how the existing requirements for the biological evaluation of medical devices must be applied to nanomedical devices.