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Biomedical Engineering / Biomedizinische Technik

Joint Journal of the German Society for Biomedical Engineering in VDE and the Austrian and Swiss Societies for Biomedical Engineering and the German Society of Biomaterials

Editor-in-Chief: Dössel, Olaf

Editorial Board: Augat, Peter / Haueisen, Jens / Jockenhoevel, Stefan / Knaup-Gregori, Petra / Lenarz, Thomas / Leonhardt, Steffen / Plank, Gernot / Radermacher, Klaus M. / Schkommodau, Erik / Stieglitz, Thomas / Boenick, Ulrich / Jaramaz, Branislav / Kraft, Marc / Lenthe, Harry / Lo, Benny / Mainardi, Luca / Micera, Silvestro / Penzel, Thomas / Robitzki, Andrea A. / Schaeffter, Tobias / Snedeker, Jess G. / Sörnmo, Leif / Sugano, Nobuhiko / Werner, Jürgen /

6 Issues per year


IMPACT FACTOR 2016: 0.915
5-year IMPACT FACTOR: 1.263

Online
ISSN
1862-278X
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Volume 61, Issue 2

Issues

Volume 57 (2012)

A UK medical devices regulator’s perspective on registries

John Wilkinson / Andy Crosbie
  • Corresponding author
  • Head of Biosciences and Implants Unit, UK Medicines and Healthcare Products Regulatory Agency, 151 Buckingham Palace Road, London SW1W 9SZ, UK, Phone: +44 20 3080 7283
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Published Online: 2016-04-20 | DOI: https://doi.org/10.1515/bmt-2015-0142

Abstract

Registries are powerful tools to support manufacturers in the fulfilment of their obligations to perform post-market surveillance and post-market clinical follow-up of implantable medical devices. They are also a valuable resource for regulators in support of regulatory action as well as in providing information around the safety of new and innovative technologies. Registries can provide valuable information on the relative performance of both generic types and manufacturer’s individual products and they complement other sources of information about device performance such as post-market clinical studies and adverse incident reporting. This paper describes the experience of the UK medical device regulator – the Medicines and Healthcare Products Regulatory Agency (MHRA) – of working with registries to monitor the safety and performance of medical devices. Based upon this experience, the authors identify a number of attributes for a registry which they consider to be key if the registry is to contribute effectively to the work of regulators on patient safety monitoring and medical device regulation.

Keywords: follow-up; implant; post-market; surveillance

References

About the article

Received: 2015-08-10

Accepted: 2016-03-18

Published Online: 2016-04-20

Published in Print: 2016-04-01


Citation Information: Biomedical Engineering / Biomedizinische Technik, Volume 61, Issue 2, Pages 233–237, ISSN (Online) 1862-278X, ISSN (Print) 0013-5585, DOI: https://doi.org/10.1515/bmt-2015-0142.

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©2016 by De Gruyter. Copyright Clearance Center

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