Radiodiagnostic Equipment: Regulations and Materiovigilance

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.

Keywords

• medical device
• ionizing radiation
• radio-diagnostic equipment
• materiovigilance
• regulations