After years of collaborative work, the MDKU community has published the first unified data model for digital technical documentation of medical devices - and meddevo supports it out of the box.

The European MedTech industry has been waiting for this moment. On February 5, 2026, DIN SPEC 91509 was officially published. The first standardized data model for the content of technical documentation of medical devices.

Developed by MDKU e.V. (Medical Device Knowledge Units), a nonprofit organization of MedTech professionals, this specification addresses one of the industry's most persistent challenges: the lack of a common, structured language for regulatory documentation.

Why This Matters

Anyone who has worked with technical documentation under the MDR knows the pain. Hundreds of regulatory documents use inconsistent terminology. Over 50% of documentation content is reused across files, yet there is no standardized way to manage it. Traceability between design, risk, clinical, and usability documents is maintained manually - if at all.

The numbers tell the story: document requirements in areas like Clinical Evaluation and Post-Market Surveillance have grown by 600% between 2017 and 2023. With roughly 33,000 MedTech companies in Europe, 95% of them SMEs, most simply lack the resources to digitalize their way out of this problem on their own.

DIN SPEC 91509 changes that equation.

What DIN SPEC 91509 Defines

At its core, the specification introduces two concepts:

  • Knowledge Topics (KTs) — regulatory templates that describe what information is required from a regulatory perspective. Each KT includes a clear definition, applicable attributes, application guidance, and the regulatory basis.
  • Knowledge Units (KUs) — the device-specific information a manufacturer creates based on the KT framework. This is the actual documentation content, structured and standardized.

Release #1 covers the intended purpose of a medical device, including:

  • Indication & Contraindication
  • Medical Condition
  • Intended User
  • Mode of Action
  • Use Environment

Future releases will iteratively expand to cover all content required under MDR Annexes II and III, with an IVDR adaptation planned as well.

The specification is published free of charge under a CC BY-ND license and is available via DIN MEDIA

From the Community, For the Community

What makes MDKU unique is its origin. This is not a top-down initiative from a regulatory authority or a proprietary standard tied to a single vendor. MDKU was built by MedTech professionals who identified a gap that no one else was filling and decided to close it themselves.

Founded in 2021, the association now runs 8 active working groups covering everything from risk management to usability engineering, with 6 more planned. All members volunteer their time. The standard is vendor-neutral, openly accessible, and designed to serve the entire ecosystem: manufacturers, notified bodies, and regulators alike.

The initiative is supported by DIN e.V. and SPECTARIS. meddevo Supports MDKU Out of the Box

As a founding member of MDKU e.V., we have been involved in shaping this standard from the very beginning. We believe that a shared, open data model is the foundation the industry needs to truly digitalize regulatory documentation.

That is why meddevo fully supports the MDKU data model natively, based on meddevo’s eTD data model. Our platform validates data structured according to DIN SPEC 91509. No custom mapping, no manual conversion.

We also offer a free tool that lets you check your MDKU XML files against the DIN SPEC 91509 schema. No account required.

The release of DIN SPEC 91509 is a milestone for the MedTech industry. We are proud to have contributed to it, and we are ready to help you put it to work.