DIN SPEC 91509:
How a standardized data model is rethinking medical technology regulation
How a standardized data model is rethinking medical technology regulation
The medical technology industry is at a turning point. While technological innovations are developing at a rapid pace, the regulatory infrastructure is struggling with structural problems: Processing times of 13 to 18 months at notified bodies are now considered normal, different interpretations of regulatory terms lead to delays, and fragmented documentation systems make standardized data exchange between manufacturers and approval bodies difficult.
On 5 February 2026, DIN SPEC 91509 was published for the first time as a standardized data model for the technical documentation of medical devices – developed by the non-profit association Medical Device Knowledge Units (MDKU) in an interdisciplinary project with over 100 members from industry, notified bodies, science and software providers. This publication marks the beginning of a systematic digitalization of regulatory data exchange processes.
The problem: lack of standards for data exchange
Every manufacturer documents technical information differently. The intended purpose of a medical device is in a Word document, risk assessments in Excel spreadsheets, clinical data in PDFs. When this information is submitted to a notified body, inspectors must first understand where to find which information and how it is structured. Depending on the product, up to 50 different sets of regulations must be taken into account, including 32 standards harmonized under the MDR alone.
The real problem is not the quality of the information, but its form: Without a standardized data model, information remains trapped in proprietary formats. It cannot be processed automatically, cannot be reused consistently and cannot be exchanged efficiently between systems. Notified bodies spend valuable time on formal structural checks instead of concentrating on content-related, risk-oriented assessment.
DIN SPEC 91509: A data model for standardized exchange
DIN SPEC 91509 addresses precisely this challenge. Release #1 focuses on the intended purpose of the medical device. This is the basis on which all other regulatory requirements are built. Sarah Panten, MDKU Board Spokesperson, explains: “With DIN SPEC 91509, we are taking a decisive step towards the urgently needed standardization of information.”
The data model precisely defines which data elements belong to the purpose, how they are structured and in which format they must be available. This makes the intended purpose machine-readable, consistent and interchangeable across system boundaries. A manufacturer can maintain the intended purpose in their system and automatically transmit it to various recipients such as notified bodies, approval authorities and internal documentation systems without manual transfers or format adjustments.
Different approaches for the same goal
DIN SPEC 91509 is not the only effort to develop data models for medical technology regulation. In research, there are projects that also deal with standardized data models, but with a different focus. While the MDKU begins with the intended purpose, research projects, for example, have chosen risk management as their starting point and investigated how risk assessments can be structured in a standardized data model.
These different approaches show: The industry has recognized that standardized data models are the key to efficient regulatory processes. The question is not whether, but how and in what order the various documentation elements are standardized. The MDKU’s iterative approach makes it possible to gather practical experience and gradually expand the data model.
The added value: efficiency through interoperability
A standardized data model creates interoperability between systems and stakeholders. Manufacturers can maintain information centrally and automatically transfer it to various documents – from the risk management file to the clinical evaluation and instructions for use. Changes are made once and propagate consistently through all dependent documents. This reduces sources of error, saves time and ensures consistency.
Notified bodies receive information in a standardized format that can be processed automatically. Consistency checks, completeness checks and traceability analyses can be carried out with software support. Inspectors can concentrate on content assessments instead of spending time on formal structural checks.
For the entire industry, this means faster approval processes. The hoped-for processing times of 13 to 18 months can be significantly reduced through more efficient data exchange processes. This creates room for innovation and ultimately improves patient care through faster access to new medical solutions.
Paving the way for digital regulation
DIN SPEC 91509 is already seen as a potential blueprint for future European regulation. Structured, interoperable data models are considered a key prerequisite for the digital transformation of regulatory processes. The European Commission is working on regulations for digital technical documentation. Standardized data models such as DIN SPEC 91509 provide the technical foundation for this.
The MDKU’s community-driven approach, in which over 100 members from various organizations have participated, ensures that the data model is practical and widely accepted. Free availability under a CC BY-ND license enables all stakeholders to use, test and further develop the data model. Manufacturers and other stakeholders are expressly encouraged to gather practical experience and provide feedback that will be incorporated into future releases.
Conclusion: From theory to practice
The practical question for companies is: How can a standardized data model be implemented in practice? DIN SPEC 91509 defines the “what” – which data elements, which structure, which format. To implement this, manufacturers need a digital infrastructure that supports this data model.
This is where solutions such as BAYOOSOFT Themis come into play. As a single source of truth for process-led, digital documentation, Themis enables the central data storage of structured information, its reuse across different documents and consistent maintenance throughout the entire product life cycle. Such systems act as technical enablers that translate standardized data models such as DIN SPEC 91509 into operational reality.
The combination of a standardized data model and powerful software infrastructure creates a decisive competitive advantage: while some companies are still struggling with fragmented documentation systems and manual transfer processes, pioneers can already lay the foundations for efficient, digital data exchange processes today. The future of medical technology regulation is digital, structured and interoperable, and it starts with standardized data models such as DIN SPEC 91509.
