Thanks, Kate, for the explanation. Does anyone know whether NICE (National Institute for Health and Clinical Practice) has any connection or influence on MHRA (medicines and healthcare products regulatory authority)?
I have the impression that NICE does a reasonable (but not perfect) job in judging efficacy, safety and cost but doesn't look at devices.
Mrs Jane Galbraith
Honorary Senior Research Associate, Department of Statistical Science, University College London
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From: email list for Radical Statistics [[log in to unmask]] on behalf of KATE BLOOR [[log in to unmask]]
Sent: 03 March 2012 12:17
To: [log in to unmask]
Subject: MHRA -what it is
The MHRA stands for, and they operate under an EU directive as the UK's 'notifiable' body for IVMD's which is in-vitro-medical devices (only NHS offiicially) i.e. tests and equipment used in medical care. The have a responsiblity for 'post-use regulation of devices' and patient safety and are part of the DOH. The are currently dealing with the breast implant issues, and more recently an article in the Independant suggests there are serious problems with NHS hip-replacements too.
The questions I circulated were really about the stastistical/ methodological methods and approaches, they use for assesing products at various points in the process of monitoring safety issues, that were brought to their attention.
I hope someone will know something about this, however, I suspect that information is not easily available.
Kate Bloor
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