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Richard N de Steiger, Brian R Hallstrom, Anne Lübbeke, Elizabeth W Paxton, Liza N van Steenbergen, and Mark Wilkinson

withdrawn worldwide in 2010. This resulted in tighter regulations regarding the introduction of monitoring for new implants ( 13 ) demonstrating the critical role of registries in post-market total joint replacement surveillance. While many joint

M M Morlock, E Gomez-Barrena, D C Wirtz, A Hart, and J P Kretzer

Directive issued in 1993. The MDR requires post-market surveillance of all class IIb and III products by the manufacturers, who have to demonstrate the clinical safety of their products on a yearly basis. This will provide a substantially higher level of

Claus Varnum, Alma Bečić Pedersen, Ola Rolfson, Cecilia Rogmark, Ove Furnes, Geir Hallan, Keijo Mäkelä, Richard de Steiger, Martyn Porter, and Søren Overgaard

recognized that enhanced post-market surveillance would be useful and an initiative called ‘Beyond Compliance’ was introduced in 2012. 58 It was named Beyond Compliance because this was voluntary and beyond the European regulatory requirements. The NJR

Tom Melvin and Marina Torre

to their device. The clinical evaluation then informs the extent to which the device manufacturer is required to further examine their device once made available on the market, by means of post-market surveillance (PMS) or post-market clinical follow

Ann Alriksson-Schmidt, Jonas Ranstam, Otto Robertsson, and Lars Lidgren

being introduced on the market. Despite this, of these 70 devices, 12 were subsequently subjected to FDA recalls during their lifespans, and no less than 765 post-market modifications were recorded. 3 Twenty-two percent of these post-market

Andrew Carr

the increased use of post-market surveillance and intends to fortify the 510(k) system. This falls significantly short of the Institute of Medicine’s recommendation to eliminate the 510(k) route. The US system will improve device recall and will

Anne Lübbeke, James A. Smith, Daniel Prieto-Alhambra, and Andrew J. Carr

difficult to bridge the gap between pre- and post-market assessment and to identify the extent and importance of treatment with implantable devices in the healthcare sector and the problems associated with it. Fragmentation may thus also be one of the

Alan G. Fraser, Rob G.H.H. Nelissen, Per Kjærsgaard-Andersen, Piotr Szymański, Tom Melvin, Paul Piscoi, and On behalf of the CORE–MD Investigators (see Appendix)

important difference; and what follow-up intervals would be recommended for assessing PROMs for specific interventions. A systematic review will assess how PROMs have been used in trials and studies for regulatory purposes and post-market surveillance, and

Anne Lübbeke, Andrew J Carr, and Pierre Hoffmeyer

industry dedicated to providing high-performance implants. 13 The registry is seen as an essential tool of post-market surveillance and clinical control that justifies improvements in materials, design and concepts. In their view the downside is that

Martyn Porter, Richard Armstrong, Peter Howard, Matthew Porteous, and J. Mark Wilkinson

post-market surveillance. Transparency and accountability The NJR is funded as part of the NHS. This leads to inevitable tensions between the politicians who want all outcome data to be published, and the surgeons who have concerns about the