A technical file is a set of documents that describes a product and can prove that the product was designed and according to the requirements of a quality management system.
CE Entry Pack. Technical File assistance: a systematic seven-step program, provided by e-mail to complete the technical documentation as required under the Regulations. This program requires an active involvement of manufacturer’s personnel. The technical file will be created according to the STED (Summary Technical DOcumentation). Preparing your CE Technical File takes precision and care, as the requirements for data, documentation, and formatting of this document are very specific. In this white paper, we demystify this important document and answer your biggest questions about how to prepare a Technical File, including: How does the Technical File fit in the CE Marking.
All products that have a CE mark must have a technical file which must contain the information that proves that the product conforms with the EU directives for CE-marked products. EU enforcement authorities may demand a copy of the technical file for many years after the last product was made. Customers do not usually have access to the technical file.
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. One document may be named 'technical file' and list all other documents that are considered part of the technical file.
A technical file includes drawings, specifications, reports, review records, meeting minutes, labels, instructions for use, software source code, etc. Annex II of the EU medical device regulation contains an overview of the contents and structure of a technical file.
The sub-clause 4.2.3 of ISO 13485:2016 requires a manufacturer of a medical device to establish a technical file (medical device file).
See also[edit]
- Device Master Record – a similar concept in the USA for medical devices
References[edit]
External links[edit]
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