Atechnical fileis 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 aCE markmust have a technical file which must contain the information that proves that the product conforms with theEUdirectives 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
editA 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 thecompetent authorityon request.
Medical devices
editThe sub-clause 4.2.3 ofISO 13485:2016requires a manufacturer of amedical deviceto establish a technical file (medical device file,device master record,design dossier,ordevice master file). Annex II and III of theEU medical device regulation(MDR) and of theIn-vitro Diagnostic Regulation(IVDR) contain an overview of the contents and structure of a technical file, here calledTechnical documentation.
See also
edit- Device Master Record– a similar concept in the US for medical devices
- Technical documentation