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

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.

Keywords: Clinical investigations; Evidence-based practice; Medical devices; Registries.

Graphical Abstract

Figure 1

Potential contributions of CORE-MD across the lifecycle of medical device development and evaluation. CORE-MD, Coordinating Research and Evidence for Medical Devices. The central horizontal panel illustrates the standard sequence for evaluating the evidence for a high-risk medical device in the EU. It does not show all the responsibilities of notified bodies. Figure adapted from Fraser et al. The green boxes correspond to specific tasks in CORE-MD. DG SANTE, Directorate General for Health; CEAR, Clinical evaluation assessment report; CE = Conformité Européenne.