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Regolamento 2024-1860 per MD e IVD

EU Regulation 2024/1860: Updates for Medical and In Vitro Diagnostic Devices

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 […]

Italia si adegua a MDR

Italy and the European Regulation on Medical Devices: Balancing Flexibility and Responsibility

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 […]