{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,11,13]],"date-time":"2026-11-13T03:02:19Z","timestamp":1794538939776,"version":"4.9.1"},"reference-count":49,"publisher":"Bioscientifica","issue":"10","license":[{"start":{"date-parts":[[2026,2,13]],"date-time":"2026-02-13T00:00:00Z","timestamp":1770940800000},"content-version":"vor","delay-in-days":1596,"URL":"https:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"content-domain":{"domain":["journals.bioscientifica.com"],"crossmark-restriction":true},"short-container-title":[],"published-print":{"date-parts":[[2021,10,1]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:p>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 \u2018conformity assessment\u2019 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 \u2013 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\u2013MD 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.<\/jats:p>\n                  <jats:p>Cite this article: EFORT Open Rev 2021;6:839-849. DOI: 10.1302\/2058-5241.6.210081<\/jats:p>","DOI":"10.1302\/2058-5241.6.210081","type":"journal-article","created":{"date-parts":[[2021,10,20]],"date-time":"2021-10-20T02:18:14Z","timestamp":1634696294000},"page":"839-849","update-policy":"https:\/\/doi.org\/10.1530\/crossmarkpolicy-16","source":"Crossref","is-referenced-by-count":28,"title":["Improved clinical investigation and evaluation of high-risk medical devices: the rationale and objectives of CORE\u2013MD (Coordinating Research and Evidence for Medical Devices)"],"prefix":"10.1530","volume":"6","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-7083-6995","authenticated-orcid":false,"given":"Alan G.","family":"Fraser","sequence":"first","affiliation":[{"name":"1Department of Cardiology, University Hospital of Wales, Cardiff, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-1228-4162","authenticated-orcid":false,"given":"Rob G.H.H.","family":"Nelissen","sequence":"additional","affiliation":[{"name":"2Department of Orthopaedics, Leiden University Medical Center, Leiden, Netherlands"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Per","family":"Kj\u00e6rsgaard-Andersen","sequence":"additional","affiliation":[{"name":"3Department of Orthopaedics, Vejle Hospital, South Danish University, Vejle, Denmark"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Piotr","family":"Szyma\u0144ski","sequence":"additional","affiliation":[{"name":"4Centre of Postgraduate Medical Education, MSWiA Central Clinical Hospital, Warsaw, Poland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Tom","family":"Melvin","sequence":"additional","affiliation":[{"name":"5Healthcare Products Regulatory Authority, Earlsfort Terrace, Dublin 2, Ireland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Paul","family":"Piscoi","sequence":"additional","affiliation":[{"name":"6Health Technology Unit B6, Directorate General for Health (DG SANTE), European Commission, Brussels, Belgium"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"name":"On behalf of the CORE\u2013MD Investigators (see Appendix)","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"416","published-online":{"date-parts":[[2021,10,19]]},"reference":[{"key":"2026070711341239600_bibr1-2058-5241.6.210081","unstructured":"European Union. 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