Improved clinical investigation and evaluation of high-risk medical devices

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Improved clinical investigation and evaluation of high-risk medical devices

the rationale and objectives of CORE-MD (Coordinating Research and Evidence for Medical Devices)

Journal Article (2022)

Author(s)

Alan Fraser (Cardiff University)

Rob Nelissen (Leiden University Medical Center)

P. Kjærsgaard-Andersen (South Danish University)

P. Szymański (MSWiA Central Clinical Hospital)

T. Melvin (Healthcare Products Regulatory Authority)

P. Piscoi (European Commission)

Alan Fraser (ESC)

Piotr Szymański (ESC)

Chris Gale (EAP)

Aldo Maggioni (ESC)

Elisabetta Zanon (ESC)

Christina Dimopoulou (ESC)

Cinzia Ceccarelli (ESC)

Polyxeni Vairami (ESC)

Anett Ruszanov (ESC)

Per Kjærsgaard-Andersen (EFORT)

Rob Nelissen (EFORT)

Adrian Ott (EFORT)

Elizabeth Macintyre (BioMed Alliance)

Loredana Simulescu (EFORT)

Marieke Meijer (BioMed Alliance)

Berthold Koletzko (EAP)

Sarah Wieczorek (EAP)

Adamos Hadjipanayis (EAP)

Stefano Del Torso (EAP)

Perla Marang-Van de Mheen (Leiden University Medical Center)

Lotje Hoogervorst (Leiden University Medical Center)

Ewout W. Steyerberg (Leiden University Medical Center)

Bas Penning De Vries (Leiden University Medical Center)

Peter McCulloch (University of Oxford)

Martin Landray (University of Oxford)

Daniel Prieto Alhambra (University of Oxford)

James Smith (University of Oxford)

Anne Lubbeke-Wolf (University of Oxford)

Stefan James (Uppsala Clinical Research Center)

Sergio Buccheri (Uppsala Clinical Research Center)

Robert Byrne (Royal College of Surgeons in Ireland)

Laurna McGovern (Royal College of Surgeons in Ireland)

Stephan Windecker (University Hospital of Psychiatry)

Andre Frenk (University Hospital of Psychiatry)

Georgios Siontis (University Hospital of Psychiatry)

Christoph Stettler (University Hospital of Psychiatry)

Arjola Bano (University Hospital of Psychiatry)

Lia Bally (University Hospital of Psychiatry)

Frank E. Rademakers (Katholieke Universiteit Leuven)

Jan D'hooge (Katholieke Universiteit Leuven)

Anton Vedder (Katholieke Universiteit Leuven)

Elisabetta Biasin (Katholieke Universiteit Leuven)

Erik Kamenjasevic (Katholieke Universiteit Leuven)

Petra Schnell-Inderst (UMIT)

Research Group

Safety and Security Science

Medical devices Clinical investigations Evidence-based practice Registries

DOI related publication

https://doi.org/10.1093/EHJQCCO/QCAB059 Final published version

To reference this document use

https://resolver.tudelft.nl/uuid:64a4314b-7665-44a9-b93d-9f6614eaf278

More Info

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Publication Year

2022

Language

English

Research Group

Safety and Security Science

Issue number

3

Volume number

8

Pages (from-to)

249-258

Downloads counter

602

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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, whereas authorizing the placing on the market of medical devices is decentralized to independent 'conformity assessment' organizations 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 (Coordinating 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.

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