[Use of cardiovascular registries in regulatory pathways: perspectives from the EU-MDR Cardiovascular Collaboratory]

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.

Keywords: Clinical registries; Clinical trials; Regulatory science.

Figure 1. Conceptual framework for the implementation of a clinical registry. Phase 1 requires building a legal and scientific framework, as well as setting up agreements and designing the overall distribution of tasks among collaborators. Phase 2 touches upon the design and implementation of the registry, where most attention is paid to data requirements, and data quality should be a common denominator. Phase 3 presents optional activities to be provided by independent parties to increase consistency, quality, and long-term reliability. Phase 4 must be readily documented and available when results are expected. All phases shall be discussed and implemented simultaneously as the final product requires having assessed these 20 components. Detailed written documentation of agreements are to be held by the executive committee of the registry. All components of phases 1, 2 and 4 are required. Phase 3 components are optional.

Figura 1. Marco conceptual para la implementación de un registro clínico. La fase 1 requiere fijar un marco legal y científico, así como también acordar y diseñar la distribución general de las tareas a realizar entre los colaboradores implicados. La fase 2 aborda el diseño e implementación del registro prestándose la mayor atención posible a los requisitos y calidad de los datos como común denominador. La fase 3 presenta actividades opcionales que pueden ser proporcionadas por partes independientes para aumentar la consistencia, calidad y confiabilidad a largo plazo. La fase 4 debe estar siempre lista y documentada cuando se esperan resultados. Todas las fases deberán ser debatidas e implementadas simultáneamente pues el producto final requiere la evaluación de estos 20 componentes. La documentación detallada, por escrito, de los acuerdos alcanzados debe obrar en poder del comité ejecutivo del registro. Todos los componentes de las fases 1, 2 y 4 son obligatorios y los de la fase 3, opcionales.