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EU-MDR Cardiovascular Collaboratory

The EU-MDR Cardiovascular Collaboratory (EU-MCVC) is an international expert network which brings together European academicians, clinical trialists, and regulatory experts to collaborate with clinical research stakeholders, regionally and globally.

The purpose of EU-MCVC is to create a dynamic and open conversation to continuously achieve an effective implementation of clinical research in Europe with emphasis on navigating the European Medical Device Regulation (EU-MDR). Relevant stakeholders to this collaboratory are cardiovascular research organizations, registry platforms, regulatory bodies, and industry partners.

EU-MCVC Founding Board

  • Dr. Ernest Spitzer - Cardialysis & European Cardiovascular Research Institute (ECRI Foundation) (Rotterdam, The Netherlands)
  • Prof. dr. David Erlinge - Department of Cardiology, Lund University Hospital (Lund, Sweden)
  • Prof. dr. Robert Byrne - Cardiovascular Research Institute at Mater Private Network & RCSI University of Medicine and Health Sciences & The Cardiovascular Research Institute Dublin (CVRI) (Dublin, Ireland)
  • Dr. Armando Pérez de Prado - Hospital Universitario de León & EPIC Foundation (Leon, Spain)

 

EU-MCVC Collaborators

  • Prof. dr. Jeroen Bax - Department of Cardiology, Leiden University Medical Center (Leiden, The Netherlands)

Deliverables 2023-2025

The deliverables of EU-MCVC include:

  • Yearly educational meeting
  • Develop on-line resources
  • Yearly white paper or publication
  • Develop the EU-MCVC Registry Network
  • Participation in international working groups

 

Accomplishments 2023-2025

First think tank on Use of Cardiovascular Registries Data in European Regulatory Pathways: Part I, which took place in Rotterdam on September 8th, 2023, including 13 Faculty and 42 registered participants, representing 9 European countries and 12 countries globally.

Faculty Picture in Rotterdam

Next steps: White paper in preparation.