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, while authorising the placing on the market of medical devices is decentralised to independent ‘conformity asssessment’ organisations 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 (Coordination of 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.

Real-World and Regulatory Perspectives of Artificial Intelligence in Cardiovascular Imaging

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“…CORE-MD is a project of stakeholders that seeks to improve research and evidence for high-risk medical devices in cardiovascular, diabetic, and orthopedic medicine by tapping real-world data, establishing registries, and advanced methodology in statistics and trial design. Responsible innovation comprises the evaluation of AI and stand-alone software as a particular focus (55).…”

Clinical evidence for high-risk medical devices used to manage diabetes: protocol for a systematic review and meta-analysis

“…In the framework of the Coordinating Research and Evidence for Medical Devices group, we will review the literature on high-risk medical devices for diabetes monitoring and treatment before and after the CE mark approval. 6 …”

“…In the framework of the Coordinating Research and Evidence for Medical Devices group, we will review the literature on high-risk medical devices for diabetes monitoring and treatment before and after the CE mark approval. 6 Toward this end, we will conduct a systematic review and meta-analysis to assess whether high-risk medical devices for diabetes…”

Validation of CORE-MD PMS Support Tool: A Novel Strategy for Aggregating Information from Notices of Failures to Support Medical Devices’ Post-Market Surveillance

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