formal policy for the identification of specific prostheses. A post-market surveillance system for medical devices should provide the following functions: readily identify underperforming devices, characterize and disseminate information about real
Richard N de Steiger, Brian R Hallstrom, Anne Lübbeke, Elizabeth W Paxton, Liza N van Steenbergen, and Mark Wilkinson
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
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
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
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
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, 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
Mustafa S. Rashid, Yves Tourné, and Kar H. Teoh
the chances of union. Utilizing a large post-market surveillance registry database, Zura et al reported an overall healing rate for all fractures sustained < 90 days prior to LIPUS treatment as 96% (4032/4190). 13 However, this cohort excluded
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
