A technical file is a set of documents that describes a product and can prove that the product was designed in accordance with the requirements of a quality management system.
All products that have a
CE mark
On commercial products, the letters CE (as the logo ) mean that the manufacturer or importer affirms the good's conformity with European health, safety, and environmental protection standards. It is not a quality indicator or a certificat ...
must have a technical file which must contain the information that proves that the product conforms with the
EU directives and regulations 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.
Content
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
competent authority
A competent authority is any person or organization that has the legally delegated or invested authority, capacity, or power to perform a designated function. Similarly, once an authority is delegated to perform a certain act, only the competent a ...
on request.
Medical devices
The sub-clause 4.2.3 of
ISO 13485:2016 requires a manufacturer of a
medical device
A medical device is any device intended to be used for medical purposes. Significant potential for hazards are inherent when using a device for medical purposes and thus medical devices must be proved safe and effective with reasonable assura ...
to establish a technical file (''medical device file'', ''device master record'', ''design dossier'', or ''device master file''). Annex II and III of the
EU medical device regulation (MDR) and of the
In-vitro Diagnostic Regulation (IVDR) contain an overview of the contents and structure of a technical file, here called
Technical documentation.
See also
*
Device Master Record{{snd a similar concept in the US for medical devices
*
Technical documentation
References
Conformance Ltd explanation about Technical FileU.S. Government export page explaining Technical File
External links
Tolerance Management
Quality management
Regulation of medical devices