Implementing the new European Regulations on medical devices—clinical responsibilities for evidence-based practice: a report from the Regulatory Affairs Committee of the European Society of Cardiology. (2nd June 2020)

• Record Type: Journal Article
• Authors: Fraser, Alan G; Byrne, Robert A; Kautzner, Josef; Butchart, Eric G; Szymański, Piotr; Leggeri, Ilaria; de Boer, Rudolf A; Caiani, Enrico G; Van de Werf, Frans; Vardas, Panagiotis E; Badimon, Lina
• Is Part Of: European heart journal. Volume 41:Number 27(2020)
• Page Start: 2589
• Page End: 2596
• Publication Date: 2020-06-02
• Subjects: Medical devices -- Regulations -- Evidence-based practice -- Registries; Cardiology -- Periodicals; Heart -- Diseases -- Periodicals; 616.12005
• DOI: 10.1093/eurheartj/ehaa382
• Languages: English
• ISSNs: 0195-668X

Abstract

Abstract: The new European Union (EU) law governing the regulatory approval of medical devices that entered into force in May 2017 will now take effect from 26 May 2021. Here, we consider how it will change daily practice for cardiologists, cardiac surgeons, and healthcare professionals. Clinical evidence for any high-risk device must be reported by the manufacturer in a Summary of Safety and Clinical Performance (SSCP) that will be publicly available in the European Union Database on Medical Devices (Eudamed) maintained by the European Commission; this will facilitate evidence-based choices of which devices to recommend. Hospitals must record all device implantations, and each high-risk device will be trackable by Unique Device Identification (UDI). Important new roles are envisaged for clinicians, scientists, and engineers in EU Expert Panels—in particular to scrutinize clinical data submitted by manufacturers for certain high-risk devices and the evaluations of that data made by notified bodies. They will advise manufacturers on the design of their clinical studies and recommend to regulators when new technical specifications or guidance are needed. Physicians should support post-market surveillance by reporting adverse events and by contributing to comprehensive medical device registries. A second law on In Vitro Diagnostic Medical Devices will take effect from 2022. We encourage all healthcare professionals to contribute proactively to these new systems, in order to enhance the efficacy and safety of high-risk devices and to promote equitable access to effective innovations. The European Society of Cardiology will continue to advise EU regulators on appropriate clinical evaluation of high-risk devices.