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Press Release
MDKU is part of the European DIGICAP project to advance digital conformity assessment for medical devices
Erlangen, September 08, 2026. Medical Device Knowledge Units (MDKU) is a consortium partner in the newly launched European DIGICAP project – DIGItalisation of the Conformity Assessment Process – bringing its experience in structured technical documentation and its open-source unified data model for medical devices into a major European initiative for the digitalisation of conformity assessment. DIGICAP is a three-year, €4 million project funded by the European Union’s Horizon Europe programme. Coordinated by Team-NB, the European Association of Medical Devices Notified Bodies, the project brings together 19 partners from across Europe, including Notified Bodies, the medical technology industry, research organisations, regulatory and legal experts. The common goal is to move conformity assessment under the Medical Device Regulation (MDR) and In Vitro Diagnostic Medical Devices Regulation (IVDR) from today’s largely document-centric processes towards a harmonised, machine-readable and interoperable digital framework.
From documents to structured data
Technical documentation for medical devices is still largely created, exchanged and reviewed in the form of documents such as PDFs and spreadsheets. While these documents contain the information required for conformity assessment, the information itself is often unstructured and therefore difficult to process digitally.
This is precisely the challenge MDKU has been addressing since its foundation in 2021. MDKU develops a unified data model that structures the content of technical documentation into individual information units – so-called Knowledge Units – and defines their regulatory meaning and relationships.
The objective is to establish a common regulatory language that enables information to be exchanged and processed independently of individual documents and software systems.
MDKU data model contributes to DIGICAP
Within DIGICAP, MDKU will contribute its existing work and expertise to the development of the project’s unified data model for technical documentation.
Building on the work of the MDKU community over the past years and the published DIN SPEC 91509, the data model will contribute to a common European data architecture for the structured exchange of regulatory information between manufacturers, Notified Bodies and other stakeholders.
“When we founded MDKU in 2021, our basic idea was quite simple: if we want to digitalize regulatory processes, we first need to structure the information behind processes and related documents and establish a common language for it. DIGICAP gives us the opportunity to bring the work of the MDKU community into a European collaboration and develop it further together with manufacturers, Notified Bodies, researchers and other stakeholders.”, explained Sarah Panten, Co-Founder and Chair of the Board, MDKU.
Towards an open European ecosystem
DIGICAP aims to develop an open, vendor-neutral framework rather than a proprietary software solution. In addition to a harmonised data architecture, the project will address interoperability standards and APIs, the responsible use of AI and automation, and real-world pilot demonstrations involving manufacturers and Notified Bodies.
For MDKU, this closely aligns with its mission of creating an open foundation for the digitalisation of regulatory processes across the MedTech ecosystem.
DIGICAP will run from 1 September 2026 to 31 August 2029.
About DIGICAP
DIGICAP – DIGItalisation of the Conformity Assessment Process – is a three-year European project funded under the European Union’s Horizon Europe research and innovation programme under Grant Agreement No. 101288338. Coordinated by Team-NB, it brings together 19 European partners to advance the digitalisation of medical device and IVD conformity assessment.
More information: digicap.eu
This project has received funding from the European Union’s Horizon Europe research and innovation programme under Grant Agreement No. 101288338. Views and opinions expressed are however those of the author(s) only and do not necessarily reflect those of the European Union or HaDEA. Neither the European Union nor the granting authority can be held responsible for them.
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
If you’re a member of the media and would like to get in touch, feel free to reach out to us at media@mdku.info.
Recording Q&A Session - DIN SPEC 91509
Please find here the recording of the Q&A session from April 29, 2026.
Invitation to Q&A Session – DIN SPEC 91509
Exploring the new DIN SPEC 91509 and its practical implications.
Following the recent publication of DIN SPEC 91509, MDKU e. V. is pleased to invite you to an open Q&A session dedicated to exploring the new specification and its practical implications.
Event details
Date & Time: 29 April 2026, 12:30–13:30 (CEST)
Location: Mircosoft Teams
Registration: No registration required. Please save the date in your calendar (see below) and join the session at the scheduled time.
This session is designed for anyone interested in the future of structured, data-driven regulatory documentation in the medical technology domain and beyond. Whether you are already familiar with the specification or just beginning to explore the topic, this event offers an opportunity to deepen your understanding and exchange perspectives.
Part 1: We will begin with a concise introduction to the motivation behind DIN SPEC 91509 and the core concepts it introduces. Participants can expect a short presentation that explains the fundamentals of the specification, outlines how knowledge can be structured into reusable units, and highlights the potential of moving from document-centric to data-centric approaches.
Part 2: The session will then transition into an extended Q&A segment. This event is intentionally designed to be driven by your questions. We strongly encourage participants to bring their perspectives, use cases, uncertainties, and ideas for discussion. Your input will shape the conversation and help create a valuable exchange for everyone involved.
If you would like to better understand DIN SPEC 91509, discuss real-world implications, or explore how the specification may affect your organization, we would be delighted to welcome you and look forward to an engaging and interactive discussion.
Press Release
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
If you’re a member of the media and would like to get in touch, feel free to reach out to us at media@mdku.info.
MDKU Medical Device Knowledge Units e.V.
Am Weichselgarten 7
91058 Erlangen
Germany