Innovation boost for the medical technology industry:
DIN SPEC 91509 introduces the first unified data model for digital technical documentation

Erlangen, February 5, 2026. The non-profit association Medical Device Knowledge Units (MDKU) e. V. has published the first release of a unified data model for the technical documentation of medical devices as a DIN SPEC. This marks the basis for a common understanding of regulatory terminology and for consistent digital implementation. Until now, room for interpretation has often led to discussions and delays in the market access process. The data model is based on the collaboration between MDKU industry experts and was reviewed and finalized as part of a DIN SPEC project by a broadly positioned  team from industry, associations, notified bodies, academia, and software providers. The new DIN SPEC 91509 is titled “Data model for the technical documentation of medical devices – Release #1: information related to the intended purpose of a medical device” and has been available  on the websites of DIN Media and MDKU.

Addressing growing regulatory challenges in medical technology

In recent years, the legal requirements of the European Medical Device Regulation (MDR) and the IVD Regulation (IVDR) have significantly increased the effort required to create and maintain technical documentation (TD). At the same time, digitalization has progressed only slowly among many manufacturers of medical device and IVD products. As a result, consistent reuse of information within a TD is often only possible to a limited extent. In addition, missing or unclear definitions of regulatory terms lead to uncertainty.

DIN SPEC 91509 addresses these challenges by providing a structured and digitally usable data foundation, the first of its kind. The data model establishes a shared understanding of regulatory requirements, reduces room for interpretation, and enables efficient, data-driven processes. This increased efficiency enables organizations to focus resources on innovation, product development, and improved patient care.

The relevance of this DIN SPEC is further strengthened by a legislative proposal published by the European Commission in December 2025 to amend the MDR and IVDR. For the first time, the draft introduces explicit provisions for the digitalization of technical documentation and conformity assessment (new MDR Article 52b and IVDR Article 48b). This represents a formal acknowledgement at the European level that structured, interoperable data models are a key prerequisite for efficient regulatory processes.

MDKU spokesperson Sarah Panten summarizes: “With DIN SPEC 91509, we are taking a decisive step toward the urgently needed standardization of regulatory information. It translates regulatory requirements into a structured, digital format and enables manufacturers, notified bodies, and other stakeholders to collaborate more efficiently while reducing unnecessary effort. Especially in light of the planned European regulations on digital technical documentation, it becomes clear how important unified, interoperable data models are for future-proof regulation – for the benefit of patients.”

Key objectives of DIN SPEC 91509

• Unified language: Precise definitions of key regulatory terms ensure clarity and consistency.
• Relief for companies and notified bodies: A common data structure simplifies the formal evaluation of content.
• Accelerated digitalization: The data model provides the basis for software-supported, data-driven processes, including consistency checks, information reuse, and traceability.
• Faster market access and improved patient care: Fewer manual and redundant tasks free up resources for innovation-driven activities.

A collaborative, open approach: from the industry, for the industry

Due to the complexity of the data model, the MDKU chose an interdisciplinary development approach. In contrast to traditional standardization projects, both the MDKU and the DIN SPEC project bring together different disciplines and perspectives from many industry experts.

The aim is to achieve broad adoption of the data model across the entire ecosystem. To support this, the DIN SPEC is freely accessible under a CC BY-ND license and may also be used for commercial purposes. The approach is already supported by industry associations such as SPECTARIS, BVMed e. V., and Swiss Medtech. DIN e. V. also supports this goal and, in addition to publishing the DIN SPEC via DIN Media, is making it available free of charge on the MDKU website – a significant step towards a modern, collaborative culture of standardization.

Further releases planned

Since the data model for all TD content required by the MDR is extensive and complex, it will be expanded iteratively. The first published release focuses on the area of “Intended Purpose/Intended Use” and includes terms such as Indication, Contraindication, Medical Condition, Intended User, Mode of Action, and Use Environment. These are considered central components of the TD.

The current release serves as proof of concept for further development. The deliberately chosen pilot approach makes it possible to gather user feedback at an early stage and continuously improve the practicality of the data model. An open feedback system is already available on the MDKU website.

Following practical validation, the model will be gradually expanded to cover all content in accordance with MDR Annexes II and III. An IVDR-adapted version of the data model is planned for the coming years. Results from other standardization activities will be taken into account with the goal of achieving long-term international harmonization.

About MDKU e. V.

MDKU e. V. is a non-profit, independent association of experts from the medical technology industry with the aim of advancing the digitalization of regulatory processes through a unified data model. The association’s motto, “From the community for the community,” underscores the collaborative approach used to solve complex challenges in the development of the data model through a multidisciplinary approach.

The association pursues exclusively non-commercial goals and makes all results openly and freely available to the community in order to enable the widest possible adoption.

Further information: www.mdku.digital

Please direct press inquiries to: media@mdku.digital

Press release available for download

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