DIGICAP: From documents to data in conformity assessment
DIGICAP is the EU-funded project that wants to replace PDFs and spreadsheets in MDR and IVDR conformity assessment with structured, machine-readable data. meddevo takes part as one of the software vendors invited to review the framework specifications.
From documents to data
What is DIGICAP?
DIGICAP stands for DIGItalisation of the Conformity Assessment Process. It is a Coordination and Support Action under Horizon Europe, funded with EUR 3,998,062 and running for 36 months from 1 September 2026 to 31 August 2029. TEAM-NB, the European association of medical device Notified Bodies, coordinates the project. Nineteen organisations from thirteen countries take part: Notified Bodies such as BSI, TÜV SÜD, DNV and GMED, MedTech Europe as the industry voice, research organisations such as RISE and VITO, legal and public health expertise, and MDKU e.V., the association behind DIN SPEC 91509.
The project's own diagnosis is that certification has become slow and hard to predict, and that the reason is not the safety standard but the exchange layer: Word files, spreadsheets and PDFs moving through manual review and repeated back-and-forth. According to DIGICAP, certifying a device takes 13 to 18 months on average, and more than half of all applications arrive incomplete.
EU contribution
Source: CORDIS
from 13 countries
Source: CORDIS
September 2026 to August 2029
Source: CORDIS
with real manufacturers and Notified Bodies
Source: digicap.eu
Three deliverables, all published openly
A consensus framework
A digital conformity assessment pathway from first contact to post-market surveillance, developed with Notified Bodies, manufacturers and regtech software vendors.
Open data schemas and ontologies
Standardised, open-source data structures so that manufacturers, Notified Bodies and software tools can exchange technical documentation without losing meaning. Published on GitHub.
A scaling roadmap
A plan for rolling the framework out across Europe, tested in at least four pilots covering medical devices, IVDs and software as a medical device, and endorsed by TEAM-NB and MedTech Europe.
What DIGICAP is not
DIGICAP is a coordination project, not a legislative act. It does not change MDR or IVDR, it creates no new obligations for manufacturers, and it does not force your Notified Body to accept structured data next year. It produces a framework, schemas, pilot results and a roadmap. What the Commission, the MDCG and the Notified Bodies then do with those outputs is a separate question.
The project is also deliberately vendor-neutral. No software vendor sits in the consortium. Vendors, meddevo included, are invited to give feedback on the specifications, not to build the framework or own it. That is the point: the data model will belong to the ecosystem, not to a tool.
DIGICAP and DIN SPEC 91509
The two initiatives work on different layers of the same problem. DIN SPEC 91509, developed by MDKU e.V., defines a data model for the content of technical documentation: which information is required, how it is structured, what it means. DIGICAP works on the process around it: how technical documentation and conformity assessment data move between manufacturers, Notified Bodies and tools, and what a harmonised digital pathway looks like from application to surveillance. MDKU is a DIGICAP consortium partner responsible for the unified data model of technical documentation, so the two are designed to fit together.
Where meddevo comes in
meddevo takes part in DIGICAP as one of the software vendors invited by the consortium to review and give feedback on the specifications for the digital conformity assessment framework. We are not a consortium member and receive no project funding. Our contribution is practical: what structured technical documentation looks like when RA and QM teams actually work with it every day, and what a manufacturer-side tool needs from the data model to be usable in a small company, not only in a large one.
Separately, meddevo is a founding member of MDKU e.V., the consortium partner leading the unified data model for technical documentation.
What you can do before 2029
Find out where your technical documentation actually lives. Not the PDF you submitted, but the source data behind it. If the answer is a folder of Word files and two people's memory, that is a risk today, independent of any EU project.
Stop treating the exported document as the source of truth. Structured, reusable content that generates the document is the model DIGICAP is building toward. The earlier your processes work that way, the smaller the transition later.
Follow the project. Schemas and framework drafts will appear on GitHub as they mature. The Stakeholder Panel is open to manufacturers. If you want a say in how the data model for your documentation looks, this is the moment.
Project timeline
Project start, kick-off in Málaga
Project start, kick-off in Málaga
First data schemas and ontologies published on GitHub
First data schemas and ontologies published on GitHub
Pilot results
Pilot results
Project end, roadmap published
Project end, roadmap published
Project updates
- September 2026
DIGICAP started on 1 September 2026. meddevo takes part as an invited software vendor.
Sources
- DIGICAP project websitehttps://digicap.eu
- CORDIS, Grant Agreement 101288338https://cordis.europa.eu/project/id/101288338
- DIN SPEC 91509 on DIN Mediahttps://www.dinmedia.de/de/technische-regel/din-spec-91509/398588664
meddevo eTD is built on the same premise DIGICAP is now formalising: technical documentation as structured data, not as a stack of documents.