Healthcare professionals will be able to receive instructions for use of medical devices in electronic format, rather than solely on paper, following a regulation of the European Commission presented. The regulation applies to all medical devices used by healthcare professionals within the EU. Professionals can still request paper versions if preferred. The adoption of electronic …
HaDEA has published the call for tenders HADEA/2025/CPN/0006 – Development of a rapid point-of-care antimicrobial susceptibility testing diagnostic medical device. This call for tenders aims to speed up the development of a point-of-care diagnostic medical device that can provide antimicrobial susceptibility testing (AST) results on the bacteria or fungi causing an infection in humans, within one hour or …
National authorities in Member States have endorsed a new strategy for the COMBINE programme, a cross-sector initiative to streamline combined studies of medicines and medical devices, including diagnostics. The COMBINE programme will be rolled out over the coming years through seven cross-sector projects. It aims to foster collaboration between national authorities responsible for clinical trials …