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Technical File

design dossier · technical documentation

TL;DR

EU MDR/IVDR documentation package covering device description, design, manufacturing, risk, clinical evidence, labelling and PMS.

Annexes II and III of EU MDR/IVDR specify the Technical Documentation a manufacturer must hold and present to its Notified Body: device description and specifications, intended purpose and classification, information supplied with the device, design and manufacturing information, GSPR (General Safety and Performance Requirements) checklist, benefit-risk analysis, risk management file (ISO 14971), product verification & validation, and the post-market surveillance / PMCF / PMPF plan and reports.

For higher-risk devices (Class III implantable, Class D IVDs) the file becomes a Design Dossier subject to full NB review.

Regulatory anchors
  • EU MDR Annex II & III
  • EU IVDR Annex II & III
How V5 handles it
Document control with hard kiosk-level training enforcement.
Versioned SOPs are only useful if operators are actually trained on the current version. V5 enforces it at the kiosk.
Related terms
EU MDRIVDRNotified BodyCE MarkingDesign controlsISO 14971BMReBMRMMRBPRBatch recordDHReDHRDMRDHFCoACoCPIF21 CFR 21121 CFR 111
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