Medical Devices Biological Safety Assessment: Towards Animal-free Testing

Animals have been used since a very long time as experimental subjects to support scientific progress and medical advances. Currently, various testing procedures implying animals are still being conducted within a broad range of scientific fields and applications, as for example the assessment of m...

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Autores principales:	Nadège Sachot, Augusto Vitale
Formato:	article
Lenguaje:	EN ES
Publicado:	Universitat Autonoma de Barcelona. Facultat de Dret 2019
Materias:	animal testing non-animal alternatives medical devices biological safety toxicology regulatory acceptance Animal culture SF1-1100 Law in general. Comparative and uniform law. Jurisprudence K1-7720
Acceso en línea:	https://doaj.org/article/7fb3177ac9354674bf2dd215b9349704
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spelling	oai:doaj.org-article:7fb3177ac9354674bf2dd215b93497042021-11-27T08:43:38ZMedical Devices Biological Safety Assessment: Towards Animal-free Testing10.5565/rev/da.3922462-7518https://doaj.org/article/7fb3177ac9354674bf2dd215b93497042019-01-01T00:00:00Zhttps://revistes.uab.cat/da/article/view/392https://doaj.org/toc/2462-7518 Animals have been used since a very long time as experimental subjects to support scientific progress and medical advances. Currently, various testing procedures implying animals are still being conducted within a broad range of scientific fields and applications, as for example the assessment of medical devices safety. The aim of this assessment is to investigate whether a medical device is safe for human use or poses a risk for patients’ health. Animal testing for that purpose is especially encouraged by regulatory requirements, which prerequisite however that the use of such testing is deemed necessary and justified in the context of a risk management process. Thus, animal models are no longer systematically used as in the past, but they remain a cornerstone within the delicate decision-making process related to the marketing of medical devices. Though, animal testing has some critical limitations, such as ethical concerns and relevance of animal data, which challenge its further use to that objective. A particular attention is therefore currently given to the development of animal-free alternatives to better support the application of the 3Rs Principle (replacement, reduction, refining) within this field. Unfortunately, the highly-advanced methods and technologies being developed face barriers (e.g. validation and standardization) which hinder and slow down their implementation as regulatory-accepted alternatives. To overcome these difficulties, the process of regulatory acceptance of these alternatives may be optimized. This may be achieved for example by improving the cooperation, coordination and communication between the different stakeholders, i.e. researchers, regulatory approval bodies and industries. Mostly, a special focus may be set on commitment and shared effort to enhance the efficiency of that process and to establish a regulatory testing framework that no longer relies on animal models. Nadège SachotAugusto VitaleUniversitat Autonoma de Barcelona. Facultat de Dretarticleanimal testingnon-animal alternativesmedical devices biological safetytoxicologyregulatory acceptanceAnimal cultureSF1-1100Law in general. Comparative and uniform law. JurisprudenceK1-7720ENESDerecho Animal, Vol 10, Iss 1 (2019)
institution	DOAJ
collection	DOAJ
language	EN ES
topic	animal testing non-animal alternatives medical devices biological safety toxicology regulatory acceptance Animal culture SF1-1100 Law in general. Comparative and uniform law. Jurisprudence K1-7720
spellingShingle	animal testing non-animal alternatives medical devices biological safety toxicology regulatory acceptance Animal culture SF1-1100 Law in general. Comparative and uniform law. Jurisprudence K1-7720 Nadège Sachot Augusto Vitale Medical Devices Biological Safety Assessment: Towards Animal-free Testing
description	Animals have been used since a very long time as experimental subjects to support scientific progress and medical advances. Currently, various testing procedures implying animals are still being conducted within a broad range of scientific fields and applications, as for example the assessment of medical devices safety. The aim of this assessment is to investigate whether a medical device is safe for human use or poses a risk for patients’ health. Animal testing for that purpose is especially encouraged by regulatory requirements, which prerequisite however that the use of such testing is deemed necessary and justified in the context of a risk management process. Thus, animal models are no longer systematically used as in the past, but they remain a cornerstone within the delicate decision-making process related to the marketing of medical devices. Though, animal testing has some critical limitations, such as ethical concerns and relevance of animal data, which challenge its further use to that objective. A particular attention is therefore currently given to the development of animal-free alternatives to better support the application of the 3Rs Principle (replacement, reduction, refining) within this field. Unfortunately, the highly-advanced methods and technologies being developed face barriers (e.g. validation and standardization) which hinder and slow down their implementation as regulatory-accepted alternatives. To overcome these difficulties, the process of regulatory acceptance of these alternatives may be optimized. This may be achieved for example by improving the cooperation, coordination and communication between the different stakeholders, i.e. researchers, regulatory approval bodies and industries. Mostly, a special focus may be set on commitment and shared effort to enhance the efficiency of that process and to establish a regulatory testing framework that no longer relies on animal models.
format	article
author	Nadège Sachot Augusto Vitale
author_facet	Nadège Sachot Augusto Vitale
author_sort	Nadège Sachot
title	Medical Devices Biological Safety Assessment: Towards Animal-free Testing
title_short	Medical Devices Biological Safety Assessment: Towards Animal-free Testing
title_full	Medical Devices Biological Safety Assessment: Towards Animal-free Testing
title_fullStr	Medical Devices Biological Safety Assessment: Towards Animal-free Testing
title_full_unstemmed	Medical Devices Biological Safety Assessment: Towards Animal-free Testing
title_sort	medical devices biological safety assessment: towards animal-free testing
publisher	Universitat Autonoma de Barcelona. Facultat de Dret
publishDate	2019
url	https://doaj.org/article/7fb3177ac9354674bf2dd215b9349704
work_keys_str_mv	AT nadegesachot medicaldevicesbiologicalsafetyassessmenttowardsanimalfreetesting AT augustovitale medicaldevicesbiologicalsafetyassessmenttowardsanimalfreetesting
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Medical Devices Biological Safety Assessment: Towards Animal-free Testing

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