CORE–MD will translate expert scientific and clinical evidence on study designs for evaluating high-risk medical devices into advice for EU regulators, to achieve an appropriate balance between innovation, safety, and effectiveness. A unique collaboration between medical associations, regulatory agencies, notified bodies, academic institutions, patients’ groups, and health technology assessment agencies, will systematically review methodologies for the clinical investigation of high-risk medical devices (Work Package 1), recommend how new trial designs can contribute (Work Package 2), and advise on methods for aggregating real-world data from medical device registries with experience from clinical practice (Work Package 3). Multidisciplinary workshops will propose a hierarchy of levels of evidence from clinical investigations; educational and training objectives for all stakeholders, to build expertise in regulatory science in Europe; and an ethics charter for medical device innovation (Work Package 4). Industry participation will be invited. Specific CORE–MD tasks will advise on optimal statistical methods, the utility of patient-reported outcomes, the conduct of registry trials, clinical criteria for evaluating artificial intelligence as a medical device, and how to evaluate medical devices used in children. The essential principles of medical device trials will be considered jointly with the Good Clinical Trials Collaborative. Links between CORE–MD partners will catalyse sustainable networks for research. The consortium is led by the European Society of Cardiology and the European Federation of National Associations of Orthopaedics and Traumatology, and involves all 33 specialist medical associations that are members of the Biomedical Alliance in Europe. Final recommendations will be submitted to the Working Group on Clinical Investigation and Evaluation of the European Commission to be considered when developing EU guidance or common specifications.

Health system barriers in vaccine uptake disproportionately affect specific ethnic, religious or cultural minorities across Europe and are therefore a major contributor to low vaccine uptake in these groups. RIVER-EU aims to identify and remove these barriers, specifically focusing on MMR and HPV vaccination in selected underserved communities (migrant community in Greece, Turkish females and Moroccan females in the Netherlands, Ukrainian minority in Poland and Roma community in Slovakia). First, we will analyze health system barriers and enablers to the vaccination of these communities, and then tailor existing interventions or develop new ones, which will be implemented and evaluated. Research findings will be translated in evidence-based guidelines and an educational platform for health care professionals that can be used to address equitable access to vaccination across Europe. We will use the Participatory Action Research approach to involve the target groups and key stakeholders, and to foster collaboration and knowledge co-creation among all stakeholders in every phase of the project. By building on existing research, findings and available information as well as on existing guidelines and recommendations, we will 1) increase understanding of the determinants of low vaccine uptake in specific contexts situated in the EU and/or Associated countries; 2) develop strategies to increase vaccination rates within these contexts; and 3) develop a series of recommendations that national and regional public health authorities could implement in order to increase vaccine coverage. Through the interdisciplinary approach and strong involvement of end-users and relevant stakeholders, we will maximize RIVER-EU’s impact by making sure the guidelines will be readily implementable, thus reducing health inequalities and improving access to vaccination services among underserved communities and increasing vaccine uptake and coverage in Europe.