Shaping the Future of Medical Device Documentation
meddevo is a proud founding member of MDKU e.V. — the nonprofit organization creating the first standardized data model for 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.
Published in February 2026, this specification covers the data model for technical documentation content — starting with intended purpose. Available free of charge under CC BY-ND license.
Release #1 Scope
- 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.