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Technical file
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<h2 id="content">Content</h2> <p>A technical file is usually based on a document archive system that ensures longevity of documents and can either be on paper or in electronic files. It can include drawings, specifications, reports, review records, meeting minutes, labels, instructions for use, software source code, production process flow charts, etc. One document may be named "technical file" and list all other documents that are considered part of the technical file but it can be made available to the <a href="/facts/Competent_authority/MnqInYCY">competent authority</a> on request. </p> <h2 id="medical-devices">Medical devices</h2> <p>The sub-clause 4.2.3 of <a href="/facts/ISO_13485/oCWA8vWz">ISO 13485:2016</a> requires a manufacturer of a <a href="/facts/Medical_device/uzUHp474">medical device</a> to establish a technical file (<i>medical device file</i>, <i>device master record</i>, <i>design dossier</i>, or <i>device master file</i>). Annex II and III of the <a href="/facts/EU_medical_device_regulation/CSXQuqo9">EU medical device regulation</a> (MDR) and of the <a href="/facts/Regulation_(EU)_2017%2f746/wP8uBBub">In-vitro Diagnostic Regulation</a> (IVDR) contain an overview of the contents and structure of a technical file, here called <a href="/facts/Technical_documentation/zFRh8FWP">Technical documentation</a>. </p> <h2 id="see-also">See also</h2> <ul><li><a href="/facts/Device_Master_Record/egrxtfj1">Device Master Record</a> – a similar concept in the US for medical devices</li> <li><a href="/facts/Technical_documentation/zFRh8FWP">Technical documentation</a></li></ul> <ul><li><a href="http://www.conformance.co.uk/info/technicalfile.php">Conformance Ltd explanation about Technical File</a></li> <li><a href="http://www.hse.gov.uk/work-equipment-machinery/technical-file.htm">United Kingdom HSE explanation of Technical File</a></li> <li><a href="http://www.export.gov/cemark/eg_main_017275.asp">U.S. Government export page explaining Technical File</a></li></ul> <h2 id="external-links">External links</h2> <ul><li><a href="https://www.casim.de/leistungen/toleranzmanagement/">Tolerance Management</a></li></ul>