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

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.

Medical Device Regulation: Should We Care About It?

“…Once a system is approved for use, clinical data have to be continuously updated through a post-market activity. It is worth noting that this complex work is also based on the contributions of several stakeholders and requires the support of independent and qualified personnel [ 12 – 14 ]. Moreover, evidence derived by the adoption of an independent medical device registry could be valuable for the whole process.…”

Decision Support Systems in HF based on Deep Learning Technologies

“…Possible solutions to cope with this limitation consist in the introduction of attention-base explainable DL methods, where the network is forced to learn on pre-defined attention maps on the original data, that can be visualized to better understand the origin of its results. An additional aspect that could limit diffusion of DL in the medical field concerns the need for clinical assessment related to the software certification as medical device, as currently regulated by the EU legislation [81]. In fact, such software must undergo approval by notified bodies before being introduced in clinical practice, and proper accuracy and increased benefit over risk need to be demonstrated a priori.…”

Digital Health: Implications for Heart Failure Management

“…for the diagnosis, prevention, monitoring or treatment of disease), make claims of health benefit, or pose potential risk of harm to patients. [ 56 ] Therefore, health technology companies are often careful to avoid medical claims and often market devices as ‘health and wellness’ products rather than tools for disease management.…”