Under Regulation (EU) 2017/745 (MDR), the labelling of medical devices plays a central role in regulatory compliance. The information provided on the label and in the Instructions for Use (IFU) must allow for the identification of the device, a clear understanding of its function, and safe usage by both healthcare professionals and patients. Manufacturers are […]
For medical device manufacturers, participating in public tenders represents a complex challenge that requires a structured approach to managing data and information. Among the key areas to focus on are tender volumes, demand planning, and product innovation. Careful preparation, following the steps outlined in this article, can make the difference between a competitive bid and […]
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 […]
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 […]
