Callea, G.; Federici, C.; Freddi, R.; Tarricone, R. Recommendations for the Design and Implementation of an Early Feasibility Studies Program for Medical Devices in the European Union. Expert Rev Med Devices2022, 1–11. https://doi.org/10.1080/17434440.2022.2075729.
This paper explores the characteristics of EFS, focusing on the studies conducted under the US FDA EFS program, started in 2013, but with implications for similar studies in Europe made possible by the International Standard ISO 14155:2020 Clinical investigation of medical devices for human subjects – Good clinical practice and provisions in the EU Medical Devices Regulation, effective since 2021. The perceptions and opinions of an expert, multidisciplinary panel of key stakeholders (clinical investigators, biomedical engineers, academics, members of scientific and professional associations, members of ethics committees, developers of new technologies) were also collected regarding the need for an ad hoc EFS program in the EU to provide a standardized procedural framework these types of pre-market studies. Findings indicate a favorable environment for an EFS program in the EU, with process, resources and ethical issues indicated as determinant factors for its effective design and implementation.
Tarricone, R.; Ciani, O.; Torbica, A.; Brouwer, W.; Chaloutsos, G.; Drummond, M. F.; Martelli, N.; Persson, U.; Leidl, R.; Levin, L.; Sampietro-Colom, L.; Taylor, R. S. Lifecycle Evidence Requirements for High-Risk Implantable Medical Devices: A European Perspective. Expert Review of Medical Devices 2020, 17 (10), 993–1006. https://doi.org/10.1080/17434440.2020.1825074.
The paper summarizes findings from an expert discussion group and supporting literature in addressing two broad research questions:
Focused on high-risk, implantable MDs, the paper provides a review of the European regulatory and HTA environments for MDs, with reference to global regulatory environments, and outlines, describes and critically discusses clinical evidence generation needs throughout the lifecycle of MDs, divided into four relevant stages: i) pre-clinical, pre-market; ii) clinical, pre-market; iii) diffusion, post-market; and iv) obsolescence & replacement, post-market.
Tarricone, R.; Banks, H.; Ciani, O.; Brouwer, W.; Drummond, M. F.; Leidl, R.; Martelli, N.; Sampietro-Colom, L.; Taylor, R. S. An Accelerated Access Pathway for Innovative High-Risk Medical Devices under the New European Union Medical Devices and Health Technology Assessment Regulations? Analysis and Recommendations. Expert Review of Medical Devices 2023, 0 (0), 1–13. https://doi.org/10.1080/17434440.2023.2192868.
This perspective article presents relevant literature and expert opinion to explore the need for an accelerated access program for medical devices in the European Union, that would combine elements of accelerated approval programs observed in other jurisdictions with post-approval evidence generation and monitoring needed for HTA, pricing and reimbursement. Leveraging learnings from accelerated approval programs worldwide, ties between the two new EU regulations, and provisions in the regulations for expert panel advice and increased stakeholder involvement, the recommendations cover various stages from the approval process through coverage and clinical uptake in the lifecycle of MDs, with the goal to safely speed patient access to innovative, life-saving technologies and increase collaboration among Member States on coverage decisions.
Stephan Windecker; Alan G. Fraser; Piotr Szymanski; Martine Gilard; Thomas F. Lüscher; Leila Abid; John Brennan; Robert Byrne; Lia Crotti; Inga Drossart; Jennifer Franke; Mario Gabrielli Cossellu; Ajay J. Kirtane; Jana Kurucova; Mitchell Krucoff; Gearóid McGauran; Patrick O. Myers; Donal B. O’Connor; Radosław Parma; Paul Piscoi; Archana Rao; Andrea Rappagliosi; Giulio Stefanini; Eigil Samset; Alphons Vincent; Ralph Stephan von Bardeleben; Franz Weidinger Priorities for medical device regulatory approval: a report from the European Society of Cardiology Cardiovascular Round Table European Heart Journal (2025), 00, 1-11
https://doi.org/10.1093/eurheartj/ehaf069
The European Union (EU) Medical Device Regulation increased regulatory scrutiny to improve the safety and performance of new medical devices. An equally important goal is providing timely access to innovative devices to benefit patient care. The European Society of Cardiology strongly advocates for the evolution of the Medical Device Regulation system to facilitate priority access for innovative devices for unmet needs and orphan cardiovascular (CV) medical devices in EU countries. Although device approval is currently executed by Notified Bodies in the EU, it will be advantageous in the mid-term to consider a single EU regulatory agency for devices. In the short term, steps can be taken to transform the current system into a more efficient, predictable, cost-effective, and user-friendly service. Key strategies include the following: enhancing predictability of the approval process through use of early scientific advice from regulators; establishing unique regulatory pathways for CV orphan, paediatric, and innovative devices; promoting more efficient (re)certification of essential legacy CV devices; improving transparency of sponsor interactions with Notified Bodies; expanding the roles of the Expert Panels to assist in the approval of CV devices; promoting global regulatory harmonization, considering streamlined authorization of CV medical technologies across selected jurisdictions; developing an efficient system to monitor device safety; and ensuring funding for data collection platforms. Some strategies that could help include considering a pilot programme for joint approval processes of selected devices in partnership with other regions (i.e. US Food and Drug Administration); developing priority pathways for accelerated access to innovative or orphan devices; and increasing recognition of the importance of early feasibility studies in the EU.