eTMF for device trials needs to hold IDE and EU MDR records, including investigator agreements, device accountability records and adverse device effect reports, keep design and software versions traceable, and retain documents for long periods. Cloudbyz eTMF is a Salesforce-native electronic trial master file that device sponsors use for this, with a configurable reference model, QC workflows and full audit trail, on the same platform as Cloudbyz CTMS and CTFM. It suits MedTech companies of every size, from early-stage developers to global multinationals.
Device records the TMF must hold
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Record
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Rule behind it
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Signed investigator agreements, including financial disclosure
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21 CFR 812.43
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Records of device shipment, receipt, use and disposition
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21 CFR 812.140
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Unanticipated adverse device effect reports and deviation reports
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21 CFR 812.150
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Clinical investigation plan, investigator's brochure and approvals
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EU Medical Device Regulation (Regulation (EU) 2017/745)
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Device versions and design changes used in the study
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Traceability for submissions
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Why retention and traceability matter more for devices
Under the EU MDR, sponsors must keep clinical investigation documentation for at least 10 years after the investigation ends, and for at least 15 years for implantable devices. In the US, IDE records must be kept for two years after the investigation ends or the records are no longer needed for a marketing application (21 CFR 812.140). Device studies also change more often than drug studies, through software updates and design iterations, so the TMF must show which device version each site used and when.
How Cloudbyz eTMF supports device studies
- Device-specific artifacts can be added to the configurable reference model, such as device accountability logs and version records.
- Agreements tracked in Cloudbyz CTFM can be filed as executed, so the TMF shows they came before site activation.
- Monitoring records from Cloudbyz CTMS, including device accountability checks, are filed when signed.
- QC and electronic signatures that meet 21 CFR Part 11, with a complete audit trail.
- Export with metadata for long-term archiving and transfer.
Cloudbyz eTMF is already used by medical device companies, including a UK precision health technology company that moved from disconnected systems to a single, inspection-ready eTMF with metadata management, search and real-time dashboards.
See a device TMF in Cloudbyz eTMF
Book a demo or visit cloudbyz.com.
