Research on Biomedical Engineering
Research on Biomedical Engineering
Review article

Impact of regulations on innovation in the field of medical devices

Rosa Mayelin Guerra-Bretaña, Andrea Lucía Flórez-Rendón

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Introduction: The regulatory framework and standardized assay methods for classical biomaterials and implantable devices are harmonized at the international level, based on the risk assessment. However, innovative products need the development of more appropriate assay methods and streamline regulatory and scientific evaluation to encourage innovation and ensure more expedite delivery of novel, safe and effective innovative medical devices to patients. The aim of this work is to review the latest focus on the conflicting issues that are involved in the evaluation of recently developed biomaterials and medical devices. Methods: This paper is based on a review of the relevant academic literature regarding the field of medical devices over the last ten years (2008-2017). A systematic search was conducted in Medline data base for articles using “medical devices” + “regulations” + “innovation” in the title or abstract. Discussion: There is the widespread perception that research and marketing of innovative medical devices are moving swifter, even more so than the issues concerning evaluation methods and regulations. Collaboration among all the stakeholders could contribute to overcome the existing problems in medical device


Medical devices, Regulations, Innovation.


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