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A. Fraser, E. Butchart, P. Szymański, E. Caiani, Scott Crosby, P. Kearney, F. Werf (2018)
The need for transparency of clinical evidence for medical devices in EuropeThe Lancet, 392
T. Maak, J. Wylie (2016)
Medical Device Regulation: A Comparison of the United States and the European UnionJournal of the American Academy of Orthopaedic Surgeons, 24
T. Hwang, Elisaveta Sokolov, J. Franklin, A. Kesselheim (2016)
Comparison of rates of safety issues and reporting of trial outcomes for medical devices approved in the European Union and United States: cohort studyThe BMJ, 353
Carsten Sommer, D. Zuccolin, V. Arnera, N. Schmitz, Pernilla Adolfsson, N. Colombo, Raphaelle Gilg, B. McDowell (2018)
Building clinical trials around patients: Evaluation and comparison of decentralized and conventional site models in patients with low back painContemporary Clinical Trials Communications, 11
Ariel Stern (2014)
Innovation Under Regulatory Uncertainty: Evidence from Medical TechnologyIRPN: Innovation & Health Law & Policy (Topic)
(2017)
New EU rules to ensure safety of medical devices
I. Poel, Z. Robaey (2017)
Safe-by-Design: from Safety to ResponsibilityNanoethics, 11
T. Melvin, M. Torre (2019)
New medical device regulations: the regulator’s viewEFORT Open Reviews, 4
A. Singal, P. Higgins, A. Waljee (2014)
A Primer on Effectiveness and Efficacy TrialsClinical and Translational Gastroenterology, 5
on Medical Devices, Amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and Repealing Council Directives 90/385/EEC and 93
J. DiMasi, Laura Faden (2011)
Competitiveness in follow-on drug R&D: a race or imitation?Nature Reviews Drug Discovery, 10
(2014)
China’s NMPA Reports Major Decrease in Medical Device Approvals https://go.nature.com/39BxzkD (EMERGO by UL, 2018)
J. Emberson, K. Lees, P. Lyden, L. Blackwell, G. Albers, E. Bluhmki, T. Brott, G. Cohen, S. Davis, G. Donnan, J. Grotta, G. Howard, M. Kaste, M. Koga, R. Kummer, M. Lansberg, R. Lindley, G. Murray, J. Olivot, M. Parsons, B. Tilley, D. Toni, K. Toyoda, N. Wahlgren, J. Wardlaw, W. Whiteley, G. Zoppo, C. Baigent, P. Sandercock, W. Hacke (2014)
Effect of treatment delay, age, and stroke severity on the effects of intravenous thrombolysis with alteplase for acute ischaemic stroke: a meta-analysis of individual patient data from randomised trialsLancet (London, England), 384
(2010)
/746 of the European Parliament and of the Council of 5 April 2017 on In Vitro Diagnostic Medical Devices and Repealing Directive 98/79/EC and Commission Decision
The European Union’s new regulatory framework for medical devices has central implications for the development of new devices, particularly by start-ups.
Nature Biomedical Engineering – Springer Journals
Published: Jun 12, 2020
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