The surge in the development of combined products, which integrate medicinal products, medical devices, and digital health technologies, presents significant challenges for pharmaceutical companies. The lack of a harmonised regulatory framework across different jurisdictions complicates the efforts, while the awareness…

Medical device–medicinal product combinations, where the primary mode of action is attributed to the device, are regulated under medical device regulations. This presentation offers a comprehensive overview of the relevant regulatory landscape, with a particular focus on Europe. It also…

The rapid advancement of medical technology brings increasing cybersecurity challenges. As medical devices and drug-device combination products integrate with wireless networks and cloud systems, they become prime targets for cyberattacks. A single breach can endanger patient safety, disrupt healthcare operations,…

Rapid advancements in digital diagnostics are revolutionising healthcare, offering unprecedented speed and precision in patient diagnosis. Connected in vitro diagnostic (IVD) devices—integrating cutting-edge sensors, sophisticated software, and seamless cloud connectivity—are at the forefront of this transformation. Yet, as these devices…