期刊
EFORT OPEN REVIEWS
卷 6, 期 10, 页码 839-849出版社
BIOSCIENTIFICA LTD
DOI: 10.1302/2058-5241.6.210081
关键词
clinical investigations; evidence-based practice; medical devices; registries
类别
资金
- European Union Horizon 2020 Research and Innovation Programme [965246]
In the EU, the management of medical devices involves collaboration between various authorities, including approval by the European Medicines Agency, conformity assessment by independent bodies, and clinical research. The latest Medical Device Regulation, in effect since 2021, provides general principles for evaluating and approving medical devices, but faces challenges in methodological details.
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.
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