Asuntos regulatorios farmacéuticos: acceso abierto

Introduction: This article provides an overview of important new regulations and policies, including some new guidance’s regarding research related to medical devices in the European Union. Also, the new timelines for submission documents. The medical device classification system has been updated to better represent the potential health concerns connected with the usage of modern high-end technologies in healthcare. Also express the major changeover that the new MDR brings to the medical devices industry, focusing on clinical investigations and clinical evaluations. The aim of this work is to give an overview of the new medical device regulations as well as the functions and activities under the European medical agency in terms of assessment, appraisal, and ongoing evaluation of medical devices. This modification ensures a high degree of safety and health via the medical device. In summary, medical device investigation protocols have been advised and authorized by competent authorities. Furthermore, the new MDR law says that the manufacturer is to be ready with a complete summary of their evidence for any high-risk devices. The alignment of the new EU MDR's evidentiary requirements is examined in this article.

Areas covered: This article discusses the guidelines and respective legislation, new content of medical devices, new features of medical devices, and new medical device clinical evaluation processes were reviewed and analysed. A systematic literature search of databases (Medline, PubMed, Google Scholar, European Medical Agency website), chosen journals, and websites turned up publications presenting novel MDR structures or the clinical evaluation and clinical investigation procedures of certain registries.

Expert commentary: This article scrutinizes the impact of new changes in medical device regulations for evaluation and conformity requirements as well as standards for new medical devices and shows that, although a high level of stability now occurs in needful requirements, there are still areas where there is a lack of methodological understanding.