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ABSTRACT On May 26, 2021, the European Medical Device Regulation (EU-MDR) entered into effect resulting in a major shift in the requirements for assessment of medical devices in Europe. The EU-MDR Cardiovascular Collaboratory (EU-MCVC) was founded to contribute to the development of faster, more efficient, and more effective pathways for innovation of cardiac medical devices. A registry is an organized system that collects uniform data and evaluates specified outcomes in a population defined by a disease, condition, or exposure. Most registries have been created to improve the quality of care and provide feedback to physicians, hospitals, and health providers. Clinical registries represent an ideal construct for scientific, clinical, and policy-making collaboration. We describe diverse experiences from 5 European countries and address the traditional quality components in clinical trials. Continued collaboration is expected among academics, clinical trialists, patient representatives, regulatory experts, research organizations, registry platforms, regulatory bodies, and industry partners. Data quality is a primary concern and registry leaders need to optimize data quality to become regulatory compliant. A collaborative approach among medical device stakeholders may improve quality of care, reduce costs, and provide faster access to innovative technologies, with the common objective of improving cardiovascular care and outcomes.

Context: Developing an effective vaccine for HIV/AIDS is a global endeavor requiring the participation of willing volunteers. Aims: To evaluate the willingness of the global population to undergo vaccination and participate in clinical trials. Methods: Following PRISMA guidelines, relevant studies published from January 2005 to December 2019 that reported quantitative, qualitative, and mixed analyses in peer-reviewed research papers were sought in the major databases. The inclusion criteria were that the studies be related to the willingness of participants to undergo HIV vaccination and submit to subsequent clinical trials, that they are in English, conducted in any geographic location, and published during the target period. The exclusion criteria were grey literature and studies involving the stakeholders, medical students or medical fraternities, seropositive parents with seronegative offspring, the vaccine’s biochemical, immunological, or financial aspects, and participants below the age of 16. Systematic reviews, letters to the editor, and case studies were also excluded. Results: The selected databases initially yielded 334 articles, of which 27 remained after applying the inclusion and exclusion criteria. Demographic data, motivating factors, and the volunteers’ willingness levels were collected and analyzed. Conclusions: This review offers guidance for future research, including a standardized scale to predict the willingness of potential volunteer groups.