Improved clinical investigation and evaluation of high-risk medical devices: the rationale and objectives of CORE-MD (Coordinating Research and Evidence for Medical Devices)

A G Fraser*, R G H H Nelissen, P Kjærsgaard-Andersen, P Szymański, T Melvin, P Piscoi, CORE-MD Investigators

*Corresponding author for this work

Research output: Contribution to journalJournal articleResearchpeer-review

Abstract

In the European Union (EU) the delivery of health services is a national responsibility but there are concerted actions between member states to protect public health. Approval of pharmaceutical products is the responsibility of the European Medicines Agency, whereas authorizing the placing on the market of medical devices is decentralized to independent 'conformity assessment' organizations called notified bodies. The first legal basis for an EU system of evaluating medical devices and approving their market access was the medical device directives, from the 1990s. Uncertainties about clinical evidence requirements, among other reasons, led to the EU Medical Device Regulation (2017/745) that has applied since May 2021. It provides general principles for clinical investigations but few methodological details-which challenges responsible authorities to set appropriate balances between regulation and innovation, pre- and post-market studies, and clinical trials and real-world evidence. Scientific experts should advise on methods and standards for assessing and approving new high-risk devices, and safety, efficacy, and transparency of evidence should be paramount. The European Commission recently awarded a Horizon 2020 grant to a consortium led by the European Society of Cardiology and the European Federation of National Associations of Orthopaedics and Traumatology, that will review methodologies of clinical investigations, advise on study designs, and develop recommendations for aggregating clinical data from registries and other real-world sources. The CORE-MD project (Coordinating Research and Evidence for Medical Devices) will run until March 2024; here we describe how it may contribute to the development of regulatory science in Europe.

Original languageEnglish
JournalEuropean Heart Journal - Quality of Care and Clinical Outcomes
Volume8
Issue number3
Pages (from-to)249–258
ISSN2058-5225
DOIs
Publication statusPublished - May 2022

Bibliographical note

Publisher Copyright:
© 2021. The author(s).

Keywords

  • clinical investigations
  • evidence-based practice
  • medical devices
  • registries
  • European Union
  • Europe
  • Humans
  • Cardiology

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