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Registry studies (CE-marked devices used within standard of care)

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  • Eve Kortleven
    14/01/2014 09:10
    I have some experience with medical device trials, conducted in compliance with the ISO 14155 standard, but am not that familiar yet with the requirements for Registry studies (CE-marked devices used within standard of care)? We tend to take the same filing approach, but now there has been a discussion on accountability responsibility. Is it the sponsor's responsibility to do - limited- accountability (e.g. just asking regularly to the site/investigator if they still have enough supplies) to ensure that the site has enough devices in stock, and is it required to document this one way or another? In general,I am interested to know what in particular the differences are in essential document filing requirements for a Registry study vs. an investigational study, taking into consideration the GCP/ISO 14155 requirements. Can you please provide me with any feedback on this.
  • Medical Devices Committee
    17/01/2014 11:10
    For Registry Studies, the device is used within the scope of its CE mark which is outside of the ISO14155 requirements. However, even if the device is used within the scope of the CE mark then ethics committee approval is required. Also, consent forms for the patients in the study along with a protocol detailing the purpose, patient population and what will be done with the data is needed. Compliance with ISO14155 would be a prudent consideration. In terms of essential documents that would depend on the system the sponsor has in place but a scaled version of 14155 requirements would be advisable. Adverse incidents or device failures would need to be recorded and reported back to the legal manufacturer. Record any post marketing safety in accordance with ethics requirements also. Such a process for monitoring SAE/SADE/complaints must be in place. The sponsor should maintain accountability and traceability for devices provided to all participating sites. Depending upon nature of device the site should maintain accountability for movement of devices i.e recording serial, batch numbers and if applicable maintain a log which patients have used device. So you would need to know what had been used, where and when and could "recall" that device if applicable or necessary.
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