title: Medical devices and safety in health care.
abstract: Medical devices have to comply with certain safety requirements. The health aspects involved require governmental involvement. Inflexibility in regulatory systems as well as numerous (legislative) measures are not compatible with the industrial interests involved. A broad survey is given of prevalent regulatory mechanisms covering medical devices at the (pre)marketing stage and at the application level. It is argued that the European Communities should unfold various activities in order to attain harmonization of legislations or other systems applied, in view of the interest of the patient on the one hand, and to further the free trade within the EC on the other hand. Some suggestions are made in this respect.
mesh_terms: D003132:Commerce; D004869:Equipment Safety; D004864:Equipment and Supplies / Q000592:standards*; D005060:Europe; D005062:European Union; D007391:International Cooperation; D007878:Legislation as Topic