Priorities for medical device regulatory approval: a report from the European Society of Cardiology Cardiovascular Round Table

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.

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Publication Details

Journal
European Heart Journal
Published
2025-02-20
DOI
https://doi.org/10.1093/eurheartj/ehaf069
Citations
4
Primary Topic
Health Systems, Economic Evaluations, Quality of Life
Type
article
Field-Weighted Citation Impact
12.52

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article

Priorities for medical device regulatory approval: a report from the European Society of Cardiology Cardiovascular Round Table

Inga Drossart, Gearóid McGauran, Radosław Parma, Jana Kurucova et al.
4 citations
European Heart Journal
Health Systems, Economic Evaluations, Quality of Life
12.52
article

Priorities for medical device regulatory approval: a report from the European Society of Cardiology Cardiovascular Round Table

Inga Drossart, Gearóid McGauran, Radosław Parma, Jana Kurucova, Lia Crotti, Martine Gilard, A. Vincent, Donal B O’Connor, Franz Weidinger, Leïla Abid, Alan G. Fraser, Archana Rao, Stephan Windecker, Ralph Stephan von Bardeleben, Ajay Jayant Kirtane, John A. Brennan, Giulio Stefanini, Jennifer Franke, Patrick O. Myers, Paul Piscoi, Eigil Samset, Robert A. Byrne, Piotr Szymański, Thomas F. Lüscher, Mitchell W. Krucoff, Mario Gabrielli Cossellu, Andrea Rappagliosi
article en
4 citations

Abstract

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.

European Heart JournalVol. 46(16)
University of Bern (CH), Valve (United States) (US), Humanitas University (IT), NewYork–Presbyterian Hospital (US), University of Sfax (TN), University of Liverpool (GB), Inserm (FR), Université de Bretagne Occidentale (FR), Medical University of Silesia (PL), King's College London (GB), University of Oslo (NO), General Electric (Spain) (ES), Johannes Gutenberg University Mainz (DE), University of Zurich (CH), Trinity College (CA), Trinity College Dublin (IE), European Commission (BE), American Association for Thoracic Surgery (US), University Hospital of Wales (GB), New York Hospital Queens (US), University Hospital of Bern (CH), Directorate-General for Health and Food Safety (BE), Harefield Hospital (GB), Medtronic (Ireland) (IE), Cardiovascular Institute Hospital (JP), Liverpool Heart and Chest Hospital (GB), Clinical Research Institute (US), University Medical Center of the Johannes Gutenberg University Mainz (DE), Institute for Postgraduate Medical Education (CZ), Health and Safety Authority (IE), Duke Medical Center (US), Mater Private Hospital (AU), IRCCS Istituto Auxologico Italiano (IT), Postgraduate School of Molecular Medicine (PL), Institute of Cardiology (PL), Austrian Competence Centre of Food Safety (AT), Cardiovascular Research Foundation (US), General Electric (Norway) (NO), Medtronic (Switzerland) (CH), Philips (Germany) (DE), IRCCS Humanitas Research Hospital (IT), University of Milano-Bicocca (IT), Columbia University (US), Edwards Lifesciences (Switzerland) (CH), University of Lausanne (CH)
Amgen, Bristol-Myers Squibb, Eli Lilly and Company, Pfizer, AstraZeneca, Sanofi, Edwards Lifesciences, Society of Thoracic Surgeons, CSL Behring, Boston Scientific Corporation, Medicure, Regeneron Pharmaceuticals, ZOLL Medical Corporation, ReCor Medical, InfraRedx, Cardinal Health, Moderna, Abiomed, European Commission, Bayer HealthCare, European Society of Cardiology, Daiichi-Sankyo, Novo Nordisk, Schweizerische Herzstiftung, Servier, Idorsia Pharmaceuticals, European Association for Cardio-Thoracic Surgery, U.S. Food and Drug Administration, Samsung, Abbott Vascular, Cilag
Partnerships for the goals
Openalex Percentile: Top 2%
Health Systems, Economic Evaluations, Quality of Life
12.52
DOIOpen Access PDFOpenAlex
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