Encuadre competencial, líneas básicas y (algunas) cuestiones aplicativas del Real Decreto 192/2023, de productos sanitarios

Abstract

This article aims to carry out an analysis of the new regulatory framework regarding medical devices derived from the approval and entry into force of Royal Decree 192/2023, on medical devices, which adapts and develops the European Union Regulation 2017/745, which meant a new paradigm shift in the European regulation of this matter. It is, therefore, a matter of carrying out a competence analysis and, likewise, of studying which novelties this manifestation of state regulatory power offers in comparison with the regulation provided for in the state regulations of 2009, also focusing on some enforcement problems and identifying possible solutions also.

Keywords

• legislation on medical devices
• new approach directives
• reprocessing of medical devices
• manufacturing in house
• competences of the eu on medical devices