E3S Web Conf.
Volume 319, 2021International Congress on Health Vigilance (VIGISAN 2021)
|Number of page(s)||8|
|Published online||09 November 2021|
Development and implementation of a system for medical devices monitoring in Morocco
1 Healthand Biology Laboratory, Faculty of Sciences, Ibn Tofail University, Kenitra, Morocco
2 Biomedical Engineering and Pharmaceuticals Sciences Research Group, ENSAM, Mohammed V University Rabat, Morocco
Given the importance of medical devices in improving health, a system of monitoring their use is necessary to ensure an acceptable benefit/risk ratio. The present study focuses on the post-marketing monitoring system, of which the aimis to develop, a national strategy for the establishment of a multidimensional vigilance system to monitor medical devices in Morocco.
Methods : The study is based on a systemic review selected by the PRISMA method for the period between [2011-2021] and on the Scopus, Pubmed, Science direct and Web of science databases.
Results: A preliminary analysis of the data identified some challenges such as under-reporting and lack of standardization of adverse reaction coding, standard nomenclature problem for international trade, lack of clarity of requirements for manufacturers, and insufficient regulation and significant incentives for the use of unique device identifiers. Recommendations for a more effective national system are put for ward which address the regulation and computerization of the system for the development of medical devices monitoring mechanisms.
Key words: Materiovigilance / medical devices / post-market surveillance / UDI / regulation
© The Authors, published by EDP Sciences, 2021
This is an Open Access article distributed under the terms of the Creative Commons Attribution License 4.0, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.
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