The integration of procurement and Health Technology Assessment (HTA) is a crucial step toward making purchasing processes more effective and value-based. This was emphasized by Guido Gastaldon, Head of the Healthcare, Goods, and Services Sourcing Division at Consip, during the AboutMedicalDevices conference. This approach is transforming public tenders, particularly in healthcare, making Health Technology Assessment […]
Health Technology Assessment (HTA) in Italy is a multidisciplinary process that synthesizes information on clinical, economic, social, and ethical aspects related to the use of a health technology in a systematic, transparent, unbiased, and robust way. The goal of HTA is to support the definition of safe, effective, and patient-centred health policies, ensuring maximum value […]
With the enforcement of the European Medical Devices Regulation (MDR), clinical evidence has become a cornerstone for regulatory compliance, as highlighted by Pietro Calamea, Director of Office VI – Clinical Investigation of Medical Devices, Directorate General of Medical Devices and Pharmaceutical Services, Ministry of Health, during the AboutMedicalDevices conference. However, contrary to expectations, there has […]
The UDI system (Unique Device Identification) has been implemented to ensure the traceability of medical devices within the European Union. Before placing a device on the market, manufacturers must: Assign a Basic UDI-DI and a UDI-PI. Place UDI carriers on the device label. Submit the information to the European database EUDAMED. Where Do We Stand […]
The introduction of the European MDR Regulation marked a turning point for medical device manufacturers, placing the generation and collection of clinical evidence and data at the core of the regulatory process. By 2024, the MDR is no longer considered a “new regulation” but rather an established system requiring precise methodological approaches and targeted strategies […]
According to Enrico Perfler, CEO of 1Med SA, a consultancy specializing in regulatory affairs, there is an increasingly evident trend among medical device manufacturers favouring the United States over Europe for conducting clinical investigations. This preference reflects significant differences in regulatory systems and market dynamics, as highlighted during his presentation at the AboutMedicalDevices conference. Manufacturers’ […]
MedTech Europe is the leading European association for the medical technology sector, including diagnostics, medical devices, and digital health. During the AboutMedicalDevices conference, Merlin Rietschel, Senior Manager of Medical Devices, Industrial Policies, analysed the state of the European medical devices industry through a survey conducted among medical device manufacturers, highlighting issues related to the implementation […]
The medical device sector in Italy is facing more complex challenges than other European countries. Despite a market valued at €12.4 billion—split 75% in public healthcare and 25% in private healthcare—and a 6.9% growth rate, 2022 saw a 30% drop in research and development investments. It remains unclear whether this situation is temporary or structural, […]
25The translation of medical device content is a highly specialized field requiring advanced linguistic skills and a deep understanding of international regulations. In this context, linguistic precision is critical, as even minor inaccuracies can compromise patient safety and device effectiveness. Translations must strictly adhere to medical regulations, such as those established by the FDA in […]
In today’s global landscape, marketing translations are essential for companies aiming to expand their international presence. A key aspect of this expansion is the ability to communicate effectively across cultures and languages without compromising authenticity or brand identity. In this article, we’ll explore the pros and cons of using AI for marketing translations, highlighting how technology […]
