DIN SPEC 91509 — The Unified Data Model for Medical Devices
The DIN SPEC 91509 defines the first standardized data model for digital technical documentation of medical devices. Developed by MDKU e.V. — meddevo is a proud founding member.
What is DIN SPEC 91509?
The DIN SPEC 91509 is the first standardized data model for the digital technical documentation of medical devices. Published in February 2026 as a DIN SPEC under the PAS (Publicly Available Specification) procedure, it was developed by the nonprofit organization MDKU e.V. in collaboration with over 180 experts from the European MedTech industry, notified bodies, and regulatory consultants.
Why a Standardized Data Model?
The European Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR) require extensive technical documentation for every medical device placed on the market. Yet until now, there was no unified structure for this documentation. Every manufacturer, notified body, and authority worked with their own formats — creating inconsistencies, redundant work, and communication barriers. The DIN SPEC 91509 solves this by providing a common language and structure for technical documentation content.
Release #1: Intended Purpose
The first release of DIN SPEC 91509 focuses on the intended purpose (Zweckbestimmung) of medical devices — one of the most critical elements of any technical documentation. The scope includes: indication and contraindication, medical condition, intended user, mode of action, and use environment. These elements are structured according to MDR Annex II and III requirements.
Knowledge Topics and Knowledge Units
The data model is built on two core concepts. Knowledge Topics (KT) define the regulatory structure — they describe which information is required, including clear definitions, attributes, guidance, and the underlying regulatory basis. Knowledge Units (KU) contain the device-specific content that manufacturers provide. This hierarchical approach ensures that documentation is both complete and consistently structured across all products and manufacturers.
License and Availability
The DIN SPEC 91509 is published under a CC BY-ND license and is freely available — including for commercial use. It can be accessed through DIN Media and the MDKU e.V. website. The specification is available as PDF, XSD, XML, and JSON formats, making it easy to integrate into existing documentation systems.
Regulatory Relevance
In December 2025, the European Commission published a legislative proposal to amend the MDR and IVDR, introducing provisions for digital technical documentation and digital conformity assessment for the first time (new MDR Article 52b). The DIN SPEC 91509 positions itself as a potential blueprint for this digital transformation — offering a ready-made, industry-consensus data model that aligns with the regulatory framework.
Roadmap
The DIN SPEC 91509 is designed for iterative expansion. Future releases will cover additional sections of MDR Annexes II and III, including risk management, clinical evaluation, and usability engineering. An IVDR-specific version is also planned. The goal is a comprehensive, machine-readable data model covering the entire scope of medical device technical documentation.
Technical Documentation is Broken
The European MedTech industry faces a documentation crisis. Regulatory requirements have exploded in complexity while the tools and processes remain stuck in the past.
Ambiguous Language
Hundreds of regulatory documents use inconsistent terminology, leaving manufacturers guessing.
Redundant Work
Over 50% of documentation content is reused across documents — yet there's no standard way to manage it.
Missing Traceability
Manual linking between design, risk, clinical, and usability documents is error-prone and time-consuming.
No Completeness Check
There's no automated way to verify that all required documentation elements are actually present.
A Unified Data Model for MedTech
MDKU — Medical Device Knowledge Units — provides a structured, open-source data model that standardizes the content of technical documentation for medical devices.
Knowledge Topic
The regulatory template describing what information is required. Includes clear definitions, attributes, guidance, and regulatory basis.
Knowledge Unit
Device-specific information created from the KT framework. Your actual documentation content, structured and standardized.
KTs define what's needed. KUs contain what you provide.
DIN SPEC 91509
The first unified data model for digital technical documentation of medical devices.
The DIN SPEC 91509 was published in February 2026 as a Publicly Available Specification (PAS) by DIN. It defines a structured, machine-readable data model for the content of medical device technical documentation — starting with Release #1 on the intended purpose (Zweckbestimmung). The specification was developed by MDKU e.V. through a consensus-based process involving manufacturers, notified bodies, consultants, and tool vendors. It is freely available under a CC BY-ND license and can be used commercially without restriction.
Release #1 Scope — Intended Purpose
- Indication & Contraindication
- Medical Condition
- Intended User
- Mode of Action
- Use Environment
Benefits for the Entire Industry
Standardized Language
Unambiguous descriptions of regulatory terms, resolving inconsistencies across hundreds of documents.
Accelerate Digitalization
A consistent foundation enabling digital solutions across manufacturers, notified bodies, and regulators.
Smart Content Reuse
Clearly distinguish where information originates vs. where it's reused — eliminating redundancy.
Automated Completeness
Enable automated verification that all required documentation elements are present.
Faster Market Approval
Fewer review iterations with notified bodies through consistent, structured documentation.
Full Traceability
Automated linking between design, verification, risk management, and usability engineering.
MedTech companies in Europe can benefit
are SMEs lacking digitalization resources
increase in document requirements (2017–2023)
active working groups
From the Community, For the Community
MDKU is driven entirely by volunteers from the MedTech industry. No commercial interests — just a shared mission to improve patient care through better documentation.
Active Working Groups
Planned
Supported by
Key Milestones
Concept Developed
Identified the need for standardization — a gap no regulatory body was addressing.
Concept Developed
Identified the need for standardization — a gap no regulatory body was addressing.
MDKU e.V. Founded
Formally registered as a nonprofit, bringing together MedTech professionals as founding members.
MDKU e.V. Founded
Formally registered as a nonprofit, bringing together MedTech professionals as founding members.
Public Launch
MDKU website published, opening the initiative to the broader MedTech community.
Public Launch
MDKU website published, opening the initiative to the broader MedTech community.
DIN SPEC 91509 Published
Release #1 — the first unified data model for digital technical documentation.
DIN SPEC 91509 Published
Release #1 — the first unified data model for digital technical documentation.
Expanding Coverage
Iterative expansion to cover all MDR Annexes II & III, with IVDR adaptation planned.
Expanding Coverage
Iterative expansion to cover all MDR Annexes II & III, with IVDR adaptation planned.
A common language for MedTech
The MDKU data model is free, open, and ready to transform how the MedTech industry handles technical documentation. You can manage your MDKU xml data with meddevo eTD.