In the medical device sector, regulatory compliance can no longer be considered an activity to be addressed only in the final stages of development. International regulations, from the European MDR Regulation to FDA requirements, demand that safety, quality and traceability be integrated throughout the entire product lifecycle, from design to commercialization. For this reason, an […]
Medical device regulation in Europe is undergoing a significant phase of evolution, with direct impacts on the implementation of Regulation (EU) 2017/745 (MDR) and Regulation (EU) 2017/746 (IVDR). Several years have now passed since the MDR and IVDR became applicable; however, while the European regulatory system can no longer be considered in its start-up phase, […]
In this article, we analyse the European Union’s strategy for the Life Sciences sector and the roadmap to 2030, exploring investments, innovation policies, regulatory simplification and digital interoperability, with particular attention to the strategic role of compliant and professional multilingual communication for companies operating in the European market. The European Union has outlined an ambitious […]
The EU Regulation 2024/1860, published in the Official Journal of the European Union on July 9, 2024, introduces significant amendments to Regulations (EU) 2017/745 and 2017/746. These amendments include new provisions for the use of the European Database on Medical Devices (EUDAMED) and additional obligations for manufacturers, as explained by Alessandra Basilisco, Biomedical Engineer, Office […]
Italy has stood out as one of the first European countries to recognize the need to postpone certain deadlines set by the Medical Device Regulation (MDR), thus averting the risk of shortages of essential devices for the European healthcare system. According to Dr. Iachino, Director General of Medical Devices and Pharmaceutical Services at the Ministry […]
