Abstract

This topic has been submitted as a request for the development of a DIN SPEC according to the PAS procedure. The application is currently being examined. DIN SPECs in accordance with the PAS procedure are developed within workshops set up on a temporary basis. This document will be developed and approved by the authors who will approve the business plan. 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 document establishes a foundation for an expedited approval process for medical devices. The document also serves as a facilitator to improve communication and the exchange of information between cross-industry partners (medical device developers, suppliers, notified bodies, certification bodies, regulatory bodies). This document does not provide requirements for other type of data models or specific data formats; nor does it establish requirements for the technical infrastructure of industry participants. This document establishes a common understanding of the technical documentation that is required for a swift and reliable transaction of information between various cross-industry partners.

Begin

2024-01-11

Planned document number

DIN SPEC 91509

Project number

62015954