Improved clinical investigation and evaluation of high-risk medical devices:the rationale and objectives of CORE-MD (Coordinating Research and Evidence for Medical Devices)
| Autor: | Arjola Bano, Stefan James, Gero Viola, Enrico G. Caiani, Frank Rademakers, Felicitas Kühne, Elizabeth Macintyre, Michael Hahn, Per Kjærsgaard-Andersen, Stephan Windecker, Anett Ruszanov, T Melvin, Richard Holborow, Anne Lubbeke-Wolf, Rob Nelissen, Sabine Ettinger, Jan Szulc, Petra Schnell-Inderst, A G Fraser, Marieke Meijer, Harry van Vugt, Juan Antonio Blasco Amaro, Peter McCulloch, Loredana Simulescu, P Kjærsgaard-Andersen, Chris P Gale, Susana L F Cabaço, Christoph Stettler, Erik Kamenjasevic, Robert E Geertsma, Jantine W P M van Baal, Ola Rolfson, Michèle Meagher, Marina Torre, Sergio Buccheri, P Szymański, Polyxeni Vairami, Cinzia Cappiello, Alan Fraser, Thomas Wejs Møller, Lorenzo Gianquintieri, Joel Jakobsson, Lia Bally, Suzanne Halliday, Aldo P. Maggioni, Hannes Jarke, Christoph Ziskoven, Lotje A. Hoogervorst, Valentina Strammiello, Marianna Mastroroberto, Juan Carlos Rejón Parrilla, Joëlle M Hoebert, Ewout W. Steyerberg, David Epstein, Sarah Wieczorek, Claudia Wild, Jan D'hooge, Alexey Shiryaev, Erman Melikyan, Stefano Del Torso, James R. Smith, Sabina Hoekstra, Paola Laricchiuta, Andre Frenk, Niall MacAleenan, Piotr Szymański, Martin J Landray, Françoise Schlemmer, Elisabetta Zanon, Core-Md Investigators, Perla J Marang-van de Mheen, Amanda Tornsö, Tom Melvin, Ann-Sofie Sonne Holm-Schou, Eugenio Carrani, Kaisa Immonen, Cinzia Ceccarelli, Stefania Ceccarelli, Filippo Boniforti, R G H H Nelissen, Ria Mahon, Adamos Hadjipanayis, Georgios Siontis, Bas B.L. Penning de Vries, Christina Dimopoulou, Robert A. Byrne, Elisabetta Biasin, Maristella Matera, Laurna McGovern, Agnieszka Dobrzynska, Berthold Koletzko, Anton Vedder, P Piscoi, Daniel Prieto Alhambra, Gearóid McGauran, Adrian Ott |
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| Jazyk: | angličtina |
| Rok vydání: | 2022 |
| Předmět: |
General Orthopaedics
medicine.medical_specialty Evidence-based practice evidence-based practice Cardiology 610 Medicine & health medical devices 03 medical and health sciences Health services 0302 clinical medicine 030225 pediatrics Clinical investigation Agency (sociology) Medicine media_common.cataloged_instance Humans Orthopedics and Sports Medicine Regulatory science 030212 general & internal medicine Registries European Union European union media_common business.industry Member states Health Policy Public health Clinical study design registries clinical investigations Public relations Transparency (behavior) 3. Good health Clinical trial Europe Core (game theory) Medical devices Surgery Cardiology and Cardiovascular Medicine business Clinical investigations |
| Zdroj: | Fraser, A G, Nelissen, R G H H, Kjærsgaard-Andersen, P, Szymański, P, Melvin, T, Piscoi, P & CORE-MD Investigators 2022, ' Improved clinical investigation and evaluation of high-risk medical devices : the rationale and objectives of CORE-MD (Coordinating Research and Evidence for Medical Devices) ', European Heart Journal-Quality of Care and Clinical Outcomes, vol. 8, no. 3, pp. 249–258 . https://doi.org/10.1093/ehjqcco/qcab059 EFORT Open Reviews, 6(10), 839-849. BRITISH EDITORIAL SOC BONE & JOINT SURGERY EFORT Open Reviews Fraser, Alan G; Nelissen, Rob G H H; Kjærsgaard-Andersen, Per; Szymański, Piotr; Melvin, Tom; Piscoi, Paul (2021). Improved clinical investigation and evaluation of high-risk medical devices: the rationale and objectives of CORE-MD (Coordinating Research and Evidence for Medical Devices). EFORT open reviews, 6(10), pp. 839-849. The British Editorial Society of Bone & Joint Surgery 10.1302/2058-5241.6.210081 Fraser, A G, Nelissen, R G H H, Kjærsgaard-Andersen, P, Szymański, P, Melvin, T & Piscoi, P 2021, ' Improved clinical investigation and evaluation of high-risk medical devices : the rationale and objectives of CORE–MD (Coordinating Research and Evidence for Medical Devices) ', EFORT Open Reviews, vol. 6, no. 10, pp. 839-849 . https://doi.org/10.1302/2058-5241.6.210081 |
| ISSN: | 2058-5241 |
| Popis: | 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, while authorising the placing on the market of medical devices is decentralised to independent ‘conformity assessment’ organisations called notified bodies. The first legal basis for an EU system of evaluating medical devices and approving their market access was the Medical Device Directive, 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. Cite this article: EFORT Open Rev 2021;6:839-849. DOI: 10.1302/2058-5241.6.210081 |
| Databáze: | OpenAIRE |
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