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From Documents to Data: How DIN SPEC 91509 and DIGICAP Are Standardising Technical Documentation in Europe

From Documents to Data: How DIN SPEC 91509 and DIGICAP Are Standardising Technical Documentation in Europe

DIN SPEC 91509 and DIGICAP explained: how Europe is turning MedTech technical documentation from documents into structured data, what Release 1's 29 Knowledge Topics cover, what the EU project DIGICAP will deliver by 2029, and where CertHub stands as an MDKU member.

14 min read

Ask anyone in Regulatory Affairs where the time goes in an MDR project, and the answer is rarely "understanding the regulation". It is copying the same intended purpose into the risk management plan, the clinical evaluation plan and the IFU, then checking that all three still say the same thing after the next change.

Europe is now working on this problem from two directions at once. DIN SPEC 91509 defines what the content of a technical file is, as a standardised data model. DIGICAP works on how that content should flow between manufacturers and Notified Bodies in a digital conformity assessment. One is a specification you can download today, the other is a three-year EU project that started in September 2026.

This article explains both, and answers a question our customers ask us regularly: yes, CertHub is a member of MDKU, the association behind DIN SPEC 91509.

The Problem Both Initiatives Address: One Fact, Many Documents

DIN SPEC 91509 describes the issue clearly. Today's technical documentation consists of many individual documents, each created and maintained on its own. Core content such as the device description or the intended purpose is therefore described again and again, for example in both the Risk Management Plan and the Clinical Evaluation Plan.

The specification also names the consequence. If the target user group is described inconsistently, as a lay person in one document and a healthcare professional in another, risk analysis can end up incomplete, and clinical data from equivalent devices may be rejected by the Notified Body.

On the Notified Body side, the DIGICAP project puts numbers on the bottleneck. According to DIGICAP, certifying a medical device takes 13 to 18 months on average, and more than half of all applications arrive incomplete, triggering new review cycles. DIGICAP's view is that the bottleneck is not the safety standard itself but the exchange layer: PDFs, Word files and spreadsheets moving through manual review.

Both initiatives come to the same conclusion: technical documentation needs to become structured data, not a stack of files.

DIN SPEC 91509: A Common Language for the Technical File

What It Is

DIN SPEC 91509 carries the title Data model for the technical documentation of medical devices – Release 1: Information related to the intended purpose of a medical device. It is a 33-page document in English, developed under DIN's PAS procedure, with edition date 2026-03. It can be downloaded free of charge from DIN Media.

A DIN SPEC under the PAS procedure is developed by a consortium and does not require the participation of all stakeholders. It is not part of the body of German Standards and its use is voluntary, but DIN notes that any DIN SPEC can later serve as the basis for a full standard.

Who Developed It

The content comes from MDKU (Medical Device Knowledge Units e.V.), a non-profit association founded in 2021 by people from the MedTech industry. The idea goes back further: in 2019, a group of industry experts assessed the benefits of a unified data model, found that no organisation was working on one, and decided to build it themselves.

The DIN SPEC project started on January 11, 2024. Its purpose was to have MDKU's internal data model reviewed by external stakeholders, including companies outside MDKU, Notified Bodies and academic institutions. The consortium named in the foreword includes, among others, MDKU, KARL STORZ, Philips Medizin Systeme Böblingen, SPECTARIS, Swiss Medtech, TÜV SÜD, Technische Hochschule Lübeck and TUD Dresden University of Technology.

How the Data Model Works: Knowledge Topics and Knowledge Units

The model is built on two terms.

Knowledge Topic (KT): a structured template for one piece of information the technical file needs, such as Intended User. It is defined once and is valid for every device.

Knowledge Unit (KU): a Knowledge Topic filled in for a specific device, for example "lay adults using the device for self-measurement at home". It is the single source of truth: maintained in one place and reused, not copied.

Each KT carries its regulatory provisions (source and interpretation), its relations to other KTs, its definition and application guidance, and version metadata. Companies can add their own company-specific KTs and group KTs into "Topic Collections" without duplicating content.

The model is deliberately tool-agnostic and does not define data formats or IT infrastructure requirements. MDKU nevertheless publishes the Release 1 model as XSD schema, XML and JSON files alongside the PDF.

What Release 1 Covers

Release 1 contains 29 Knowledge Topics, all centred on the intended purpose of a device. They fall into five groups:

  • Purpose and use: intended purpose/intended use and its statement, medical purpose, mode of action, operating principle
  • Users and environment: intended user, user group, user profile, normal condition of use, use environment
  • Clinical context: medical condition, medical procedure, indication, contra-indication, intended patient population, clinical benefit, clinical performance
  • Safety information: information for safety, precaution, warning, restriction and limitation of use, complication, undesirable side-effect
  • Device context: accessories, compatible devices, type of application, part of the body or type of tissue interacted with

Release 1 also explicitly excludes four terms that overlap with existing KTs, such as "clinical condition" (versus "medical condition") and "principle of device operation" (versus "operating principle"), to keep the regulatory vocabulary unambiguous.

What Comes Next

MDKU's initial goal is a data model for all technical documentation content in MDR Annex II and Annex III, developed iteratively over several releases. Once the MDR model is complete, an IVDR-specific model is planned. There is no fixed date for the complete model: the specification states that the pace depends on community engagement and feedback.

DIGICAP: A Common Digital Process for Conformity Assessment

What It Is

DIGICAP stands for DIGItalisation of the Conformity Assessment Process. It is a Horizon Europe Coordination and Support Action (grant agreement 101288338) running from September 1, 2026 to August 31, 2029, with an EU contribution of EUR 3,998,062. It is coordinated by TEAM-NB, the European association of medical device Notified Bodies.

The consortium has 19 partners in 13 countries, including 11 Notified Bodies. Alongside Notified Bodies such as BSI, DNV, GMED and TÜV SÜD, it includes MedTech Europe, research organisations such as RISE and VITO, and MDKU.

What It Will Deliver

DIGICAP has three specific objectives:

  1. A consensus framework describing a digital conformity assessment pathway, developed with Notified Bodies, manufacturers and regtech software vendors.
  2. Open-source, standardised data schemas and ontologies, so that conformity assessment tools can interoperate.
  3. A scalable digitalisation roadmap for Europe that the ecosystem agrees on.

The framework will be tested in at least four pilots with manufacturers and Notified Bodies, covering medical devices, IVDs and medical device software. The project's stated targets include 60% of applications being complete on first submission, 25% fewer requests for missing information, and 3 to 6 months earlier patient access. Main results are to be published openly on the project website and on GitHub.

What It Is Not

DIGICAP is a coordination and support action that delivers a framework, pilots and a roadmap. It is not a change to the MDR or IVDR, and it does not by itself create new obligations for manufacturers. How regulators and Notified Bodies adopt its results will be decided after the project.

How DIN SPEC 91509 and DIGICAP Fit Together

The two initiatives are complementary layers, not competitors.

DIN SPEC 91509 is the common language. It answers the question what belongs in a technical file and how that content is structured. It is a DIN SPEC developed under the PAS procedure, led by MDKU e.V. and the DIN SPEC consortium. Release 1 is published (edition 2026-03), covers 29 Knowledge Topics on the intended purpose, and is free to download.

DIGICAP is the common process. It answers the question how structured content should move through conformity assessment. It is a Horizon Europe Coordination and Support Action, coordinated by TEAM-NB with 19 partners, running from September 2026 to August 2029. It will deliver a framework, data schemas, at least four pilots and a roadmap, with results to be published openly.

The link between them is MDKU. The association that developed the DIN SPEC data model is a funded DIGICAP consortium partner, and DIGICAP lists "data model" among its project keywords and open-source data schemas among its objectives. The organisation behind Europe's first standardised data model for technical documentation is therefore at the table where the digital conformity assessment framework is being designed.

The Timeline at a Glance

  • 2019: industry experts start the unified data model initiative
  • 2021: MDKU e.V. is founded
  • December 2023: the DIN SPEC 91509 business plan is published
  • January 11, 2024: the DIN SPEC 91509 project starts
  • Edition 2026-03: DIN SPEC 91509 Release 1 is published
  • September 1, 2026: DIGICAP starts
  • August 31, 2029: DIGICAP ends

Where CertHub Stands

CertHub is a member of MDKU e.V. That membership reflects how we built CertHub from the start: technical documentation as connected, structured data in which each piece of information lives in one place and is reused wherever the technical file needs it. This is the single-source-of-truth principle that DIN SPEC 91509 describes.

Aligned with DIN SPEC 91509 Release 1. CertHub's data model covers the Knowledge Topics defined in DIN SPEC 91509 Release 1.

Broader than Release 1 today. Release 1 covers the intended purpose, but a CE-ready technical file needs far more: risk management, clinical evaluation, verification and validation, post-market surveillance and more. CertHub's data model therefore already goes significantly beyond DIN SPEC 91509 Release 1.

Continuously aligned with future releases. As MDKU publishes further releases towards full MDR Annex II and III coverage, we align our data model with each one, so your structured documentation stays compatible with the shared European vocabulary. As DIGICAP publishes its open schemas, we will follow those as well.

What RA and QM Teams Can Do Now

You don't need to wait for 2029 to benefit from this direction.

  • Read Release 1. It is free and 33 pages long. Compare its 29 Knowledge Topics with how your intended purpose content is spread across your current documents.
  • Find your duplicates. Wherever the intended user, indications or warnings are written out in several documents, you have the inconsistency risk DIN SPEC 91509 describes.
  • Treat the exported PDF as an output, not the source. Keep the content structured and generate documents from it.
  • Give feedback. MDKU invites feedback on the data model through the feedback form on its website.
  • Follow DIGICAP. Stakeholder Panel registration closed on October 30, 2026, but results will be published on the project website and GitHub.

Frequently Asked Questions

Is CertHub a member of MDKU? Yes. CertHub is a member of MDKU (Medical Device Knowledge Units e.V.).

Is DIN SPEC 91509 mandatory? No. It is a DIN SPEC developed under the PAS procedure and not part of the body of German Standards. It is a voluntary, free-of-charge specification.

Does DIGICAP change the MDR or IVDR? No. DIGICAP is a Horizon Europe Coordination and Support Action delivering a framework, open data schemas, pilots and a roadmap.

Will DIN SPEC 91509 cover the full technical file? That is the plan: MDKU aims to cover all content in MDR Annex II and III over several releases, with an IVDR model to follow. No completion date has been set.

The Bottom Line

DIN SPEC 91509 gives Europe's MedTech industry a shared vocabulary for the technical file. DIGICAP is building the digital process that this vocabulary will travel through. Together they mark a clear shift from documents to data.

CertHub is part of that shift as an MDKU member, with a data model that already covers DIN SPEC 91509 Release 1, goes well beyond it, and is kept aligned as the standard grows.

Sources:

Disclaimer: This article is for informational purposes only and does not constitute legal or regulatory advice. DIN SPEC 91509 is a voluntary specification and DIGICAP is an ongoing research and coordination project; neither changes the requirements of the MDR or IVDR. All references are based on publicly available sources as of November 2026.