The central role of the dentist in the treatment of oncology patients is to care for the patient’s oral cavity before, during, and after radio/chemotherapy. The aim of this research was to determine the knowledge of dental students from five universities in three neighboring countries, Croatia (Split, Rijeka, and Zagreb), Bosnia and Herzegovina (Sarajevo), and Slovenia (Ljubljana), about oncology patients’ dental care. A total of 140 students in their fourth, fifth, and sixth year of dental medicine studies participated in this research. A questionnaire with 36 specific questions was designed for this research and included questions about dental care of oncologic patients before, during, and after the oncology therapy. Most students are familiar with the incidence and most common type of head and neck tumors, while knowledge about tumor treatment and the side-effects of radiation therapy and/or chemotherapy is weak. Students did not show satisfactory knowledge about osteoradionecrosis, which is the most serious side-effect of radiotherapy; therefore, the emphasis on additional education should be greatest in this area. Teaching staff should be aware of lack of student knowledge and try to offer more information and practice in providing dental care for oncology patients.

Introduction: High-risk and innovative medical devices (MDs) and in vitro diagnostic devices (IVDs) in the European Union are subject to increasingly stringent and evolving regulatory requirements. This scoping review maps methodological approaches to evidence generation across their life cycle. Methods: A comprehensive and systematic search of major bibliographic databases and grey literature sources was conducted (January 2025, updated November 2025). Studies were selected through dual independent screening using predefined inclusion criteria. Data were extracted using a structured approach and supported by AI-assisted thematic analysis. Findings were synthesized narratively to map methodological approaches to evidence generation and evaluation. Results: A total of 15,679 records were identified, with 14,259 remaining after duplicate removal and 859 full texts assessed for eligibility. Of these, 90 studies met the inclusion criteria. In addition, records identified through other methods were screened, with 75 progressing to full-text assessment; of these, 8 were included . Evidence generation for high-risk and innovative MDs and IVDs requires an integrated, life-cycle approach combining multiple study designs. While randomized controlled trials remain important, observational studies, real-world evidence, registries, and post-market surveillance are essential for assessing long-term safety and effectiveness. However, current practices show substantial variability, methodological limitations, and regulatory inconsistencies. Conclusions: An integrated lifecycle approach is needed for robust evaluation of high-risk and innovative MDs and IVDs. Strengthening methodological standards, improving the quality of real-world data, and enhancing regulatory harmonization are essential. Systematic Review Registration: Open Science Framework (OSF), doi: 10.17605/OSF.IO/XNBSP.

Background: High-risk and innovative medical devices, as well as in vitro diagnostic medical devices, often pose challenges for conventional clinical evaluation because randomized clinical trials may be difficult to conduct. As a result, methodologies for integrating heterogeneous evidence and conducting bridging studies are becoming increasingly important in regulatory decision-making and health technology evaluation. Objective: To map methodologies for evidence integration and bridging studies in high-risk and innovative medical devices and in vitro diagnostic medical devices, and to identify key methodological and regulatory challenges. Methods: A scoping review following Joanna Briggs Institute guidance was conducted using peer-reviewed and grey literature published from 2017 onward. Bibliographic databases, industry resources, and preprint platforms were searched. Included records addressed methods for comparing or integrating evidence for medical devices and in vitro diagnostic medical devices. Data extraction and synthesis were supported by artificial-intelligence-assisted analysis, with human verification. Results: Nineteen studies were included. Identified methods included Bayesian evidence synthesis, adaptive trial designs, indirect comparisons, propensity score methods, real-world data integration, linked evidence frameworks, in silico approaches, and bridging studies. These methods support evaluation when conventional randomized clinical trials are limited or infeasible. Major challenges included evidence heterogeneity, bias, limited methodological standardization, and variable regulatory acceptance, particularly for in vitro diagnostic medical devices and digital technologies. Conclusion: Evidence integration methodologies are increasingly important in the evaluation of innovative medical devices and in vitro diagnostic medical devices. However, clearer methodological standards and harmonized guidance are still needed to support consistent and reliable use of heterogeneous evidence. Systematic review registration: The scoping review was registered with the Open Science Framework (OSF). The Unique Identifier is 10.17605/OSF.IO/XNBSP, and the registration is publicly available at https://doi.org/10.17605/OSF.IO/XNBSP .