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

E Spitzer*, JMD Hernandez, IJ Guomundsdottir, E Mcfadden, C Held, C Hanet, E Boersma, CB Ren, V Delgado, D Erlinge, APD Prado, JJ Bax, JGP Tijssen

*Corresponding author for this work

Research output: Contribution to journalReview articleAcademicpeer-review

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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.
Original languageEnglish
Number of pages10
JournalREC: Interventional Cardiology
DOIs
Publication statusE-pub ahead of print - 1 Mar 2024

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