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medical devices in surgical

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  • Anon
    23/11/2012 11:56
    Medical devices in surgical trials. My understanding is that the medical devices directives apply to non-CE marked devices. Therefore for a surgical trial involving the use of a CE-marked medical devices employed for it's intended use the Medical Devices regulations would not apply nor would the trial fall within the remit of the UKSI 2004 1031 regulations or ISO 14155:2011. The trial would still need to be conducted in line with CPMP/ICH/135/95 and Research governance framework for health and social care. For safety reporting, reports to Adverse Incident Centre completed for any related AE/SAE and quaranteen of the device would be completed. Are there further guidance/directives/regulations that should be considered?
  • Medical Devices Committee
    16/01/2013 17:15
    If you do a study with a CE-marked device and only collect data that are within standard of care (often called a registry or observational study), you only need to obtain Ethics Committee approval. These studies usually do not follow ISO 14155.
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