Nanomaterials in medical devices: regulations' review and future perspectives

Karolina Jagiełło , Anita Sosnowska , Alicja Mikołajczyk , Tomasz Puzyn


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.
Author Karolina Jagiełło (FCh / DEChR / LECh)
Karolina Jagiełło,,
- Laboratory of Environmental Chemometrics
, Anita Sosnowska (FCh / DEChR / LECh)
Anita Sosnowska,,
- Laboratory of Environmental Chemometrics
, Alicja Mikołajczyk (FCh / DET / LPh)
Alicja Mikołajczyk,,
- Laboratory of Photocatalysis
, Tomasz Puzyn (FCh / DEChR / LECh)
Tomasz Puzyn,,
- Laboratory of Environmental Chemometrics
Journal seriesJournal of Nanotoxicology and Nanomedicine, ISSN 2379-7452, e-ISSN 2379-7444, (0 pkt)
Issue year2017
Publication size in sheets0.5
Article number1
Keywords in EnglishAdvanced therapy medicinal products, engineering nanomaterials, EU regulations, medical devices, Nano-Bio-Materials, risk assessment, risk management, safety assessment
Languageen angielski
Score (nominal)5
Score sourcejournalList
ScoreMinisterial score = 5.0, 04-02-2020, ArticleFromJournal
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