Technical File
A technical file is the proof that product complies with the essential safety and health requirements set down by the relevant directives. Talking about medical devices, it demonstrates compliance with essential requirements ( set out in Annex I of MDD).
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The Technical File is required for all types of classes. It is true that notified bodies will not review a technical for class I devices (as no third party is required). For Class III devices, the technical file is called Design Dossier.
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The manufacturer needs to prepare the technical file prior to affixing the CE mark. The manufacturer or its authorized representative must make this documentation. And most importantly, needs to keep the document up-to-date and demonstrate how is maintained.
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WRITE TECHNICAL FILE
Use the GUIDE to learn what should be included in the .
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Use CEEASY's template. You will save a lot of time!
CEEASY offers an example of a Technical File for a medical device called B·Tell.
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Download also the Quality Manual System of B·Tell.
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