ABSTRACT
However, in 2014 the EC Scientific Committee on Emerging and Newly Identified Health Risks (SCENIHR) published a Preliminary Opinion on the Guidance on the Determination of Potential Health Effects of Nanomaterials Used in Medical Devices. This stimulated discussion of the borderline and combination product
considerations of nanomaterials. As a result of comments made on the Preliminary Opinion, additional text and clarification on these topics was added to the final document, published January 2015. The reader is referred to the comments document for detailed discussion of particular products and borderline/combination issues [2]. In addition to recognition that similar products may be regulated as either medical devices or medicinal products (which will be dependent on claimed mode of action, supporting scientific evidence and/or interpretation by regulatory bodies) it was noted that there is a divergence in data requirements between EU and US for the same product. Also, a particular challenge is the subject of complex combination products involving nanotechnologies, e.g., a combination may include one or more medical devices in addition to an injected “medicinal product”. Various combinations of drugs, nanomaterials and activating devices are possible and these combination products are increasingly likely in the future. The document primarily focusses on medical devices, however, it is helpful that reference to the EMA’s reflection papers on injectable nanomedicines is included [2]. During the writing of this chapter, another useful reference was published by RIVM, The National Institute for Public Health and the Environment, The Netherlands, entitled “Assessing health and environmental risks of nanoparticles: current state of affairs in policy, science and areas of application.” The reader is referred to the very useful Chapter 6 on Nanomedicine, discussing the regulation of both medical devices and medicinal products and questioning whether the currently used risk assessment strategies and testing methods provide a sound scientific basis for adequate evaluation of the quality, safety and efficacy of these products within the current regulatory frameworks [3].
