Abstract

This DIN SPEC in accordance with the PAS procedure has been drawn up by a DIN-SPEC-consortium set up on a temporary basis. This DIN SPEC has been developed and approved by the authors named in the foreword. This document defines terms, definitions, and general requirements for a data model intended for categorization of information in the technical documentation of medical devices. This includes: – a provision of general information about the background of the project and expected benefits; – a description of the data model development procedure; – information about the data model structure; – a first collection of data model elements that belong to the "intended purpose information collection" (first release); – information about the initial application of the data model and feedback collection. This document establishes a common understanding of elements required in the technical documentation for medical devices – required for a swift and reliable transaction of information between various cross-industry partners. Therefore, the content of this document serves as a facilitator to simplify communication and the exchange of information between different stakeholders in the medical technology sector (e.g. medical device manufacturers, suppliers, notified bodies, certification bodies, regulatory bodies). This document does not define requirements for other types of data models or specific data formats, nor does it set requirements for the technical infrastructure of industry stakeholders intending to implement and use the data model.

Begin

2024-01-11

Planned document number

DIN SPEC 91509

Project number

62015954