Abstract
The use of medical devices (MDs) in the field of medical imaging has always been governed by rigorous regulations, in particular the authorizations and compliance of radiological installations and premises in view of the risks generated by the ionizing radiation produced by these MDs. The regulatory bases that deal with equipment emitting ionizing radiation are diversified between those specific to the protection of the public and users of ionizing radiation and those relating to medical devices. In addition, radio-diagnostic equipment must provide all the guarantees in terms of the balance between benefits and risks. Although radiation protection is essential, materiovigilance is one of the key elements of technological monitoring and surveillance of the risks that may result from the use of these medical devices after they have been placed on the market. The Moroccan legislation has a legal arsenal in accordance with the model of the World Health Organization’s global regulatory framework for medical devices. It outlines regulations and adheres to international guidelines in the field of vigilance against ionizing radiation. However, it is necessary to move on to the specification of procedures in order to remove any ambiguity.
Highlights
Regulation of the use of medical devices (MDs) in medical imaging is necessary because of the high cumulative risks of ionizing radiation that have a significant impact on health [1]
The legal arsenal is a fundamental pillar for guaranteeing the materiovigilance of this equipment and clarifying the procedure for reporting incidents and accidents caused by ionizing radiation in a context of health vigilance
The aim of this study is to analyze the regulatory basis of radiological equipment and to highlight the materiovigilance of diagnostic radiological equipment and its role in improving the health of persons exposed to ionizing radiation in order to better rationalize the management of risks associated with care
Summary
Regulation of the use of medical devices (MDs) in medical imaging is necessary because of the high cumulative risks of ionizing radiation that have a significant impact on health [1]. The regulation of radiological diagnostic equipment must be complete and rigorous, from the classification of the MD to the quality management system, in order to clear up any confusion in design, manufacture and use. The legal arsenal is a fundamental pillar for guaranteeing the materiovigilance of this equipment and clarifying the procedure for reporting incidents and accidents caused by ionizing radiation in a context of health vigilance. The aim of this study is to analyze the regulatory basis of radiological equipment and to highlight the materiovigilance of diagnostic radiological equipment and its role in improving the health of persons exposed to ionizing radiation in order to better rationalize the management of risks associated with care
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