DIN SPEC 91509:2026-03 [provided in advance]
"Data model for the technical documentation of medical devices - Release #1: Information related to the intended purpose of a medical device; Text English"
Reference: https://www.dinmedia.de/en/technical-rule/din-spec-91509/398588664
The so-called EU Medical Device Regulation 2017/745 (MDR) requires the preparation of technical documentation to demonstrate compliance with the essential requirements (Annexes II and III).
A data model for the technical documentation of medical devices was developed with this DIN SPEC, which was drawn up using the PAS process. This DIN SPEC has created a uniform regulatory structure for technical documentation and is intended to provide effective support for the implementation of the MDR.
This DIN SPEC is also a potential milestone in the context of SMART standards (in German https://www.dke.de/idis/smart-standards). SMART Standards are already being used in the GLOBALNORM software solutions GLOBALnorm (standards management system) and ATERIOS (product compliance network).
Author's note
This article has been machine translated into English.
