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…

Companion diagnostics (CDx) play a crucial role in precision medicine by identifying patients most likely to benefit from specific therapies. Under the EU In Vitro Diagnostic Regulation (IVDR), CDx are classified as class C devices, and conformity assessment for market…

Personalised Medicine and Individualised Therapies have rapidly evolved in recent years, with a focus on bringing forth the “right medication for the right patient”. Although these treatment options offer a tailored medicine that can tremendously benefit the patient, the ability…

Facilitating the development and authorisation of medicines used in combination with medical devices including companion diagnostics is a key priority for the EU regulatory network. As innovative treatments increasingly integrate medicinal products with medical devices or in vitro diagnostics, navigating…