Ireland’s HPRA opened applications to enroll sponsors in the EU COMBINE pilot scheme for drug-device trials. The program allows combined studies to be assessed through a coordinated approach when a medicine is tested alongside a combination medical device or advanced therapies, aiming to reduce duplicate paperwork and streamline authorization. Under current EU rules, drug trials follow the Clinical Trials Regulation while devices and in-vitro diagnostics are cleared under the MDR or IVDR—often creating administrative friction for combined investigations. COMBINE was designed by the European Commission to streamline reviews for medicines combined with devices or diagnostics. HPRA said Phase 1 previously accepted applications focused on multinational drugs with in-vitro diagnostic performance studies and that Phase 2 will run for the next 12 months with the next application slot closing November 23.