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Nanomaterials in Medical Devices: Regulations' Review and Future Perspectives
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Author(s): Karolina Jagiello (QSAR Lab Ltd, Gdansk, Poland & Laboratory of Environmental Chemometrics, Faculty of Chemistry, University of Gdansk, Poland), Anita Sosnowska (QSAR Lab Ltd, Gdansk, Poland & Laboratory of Environmental Chemometrics, Faculty of Chemistry, University of Gdansk, Poland), Alicja Mikolajczyk (Laboratory of Environmental Chemometrics, Faculty of Chemistry, University of Gdansk, Gdansk, Poland)and Tomasz Puzyn (QSAR Lab Ltd, Gdansk, Poland & Laboratory of Environmental Chemometrics, Faculty of Chemistry, University of Gdansk, Poland)
Copyright: 2017
Volume: 2
Issue: 2
Pages: 11
Source title:
Journal of Nanotoxicology and Nanomedicine (JNN)
Editor(s)-in-Chief: Bakhtiyor Rasulev (North Dakota State University, USA)
DOI: 10.4018/JNN.2017070101
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Abstract
This article gives a brief description of the existing regulations related to biomaterials safety that need to be considered before it is introduced into EU market. According to these regulations, the risk analysis should include two characteristics: probability of occurrence of harm, and severity. Identified user-related harm should be reduced by managing the risk. Additionally, the review presents an overview of engineered biomaterials (EBMs), which in combination with nanoscale components (NPs) have shown promises in Advanced Therapy Medicinal Products (ATMP) and Medical Devices (MD). In this article, recent challenges, objectives and perspectives in risk assessment and risk management of ATMP and MD composed of nanobiomaterials were also highlighted.
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