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. 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, device master record, design dossier, or device master file). 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 on request. It can include drawings, specifications, reports, review records, meeting minutes, labels, instructions for use, software source code, production process flow charts, etc. Customers do not usually have access to the technical file.Ī 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.

EU enforcement authorities may demand a copy of the technical file for many years after the last product was made. 3.2 The NB should ensure that the manufacturer’s application adequately describes the design, manufacture and. 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.Īll 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 and regulations for CE-marked products. - Technical documentation Technical File/Design Dossier (CE), Design History File (US). 3.1 The NB must examine the application for examination of the design dossier and, if the product conforms to the relevant provisions of the Directive, issue the application with an EC design-dossier certificate.

Design dossier definition