Average time to certify a medical device, often longer for complex technologies.
Horizon Europe · Grant Agreement 101288338
DIGICAP
From individual files to a data-driven process
An open, harmonised digital framework for medical device certification in Europe, built to make conformity assessment faster, clearer and more interoperable across the MDR and IVDR ecosystem.
36 months
Sep 2026 - Aug 2029
0
partners across Europe
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Notified Bodies
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minimum pilot tests
0%
target shorter processing times
Explainer video
DIGICAP in one minute
Why medical device certification needs to move from documents to data, how DIGICAP will get there, and who is behind it.
Read the video transcript
- Every medical device in Europe must prove it is safe before it reaches patients.
- Today, that proof travels as PDFs, Word files and spreadsheets, back and forth between manufacturers and Notified Bodies, again and again.
- Certifying a medical device takes 13-18 months on average, and more than half of applications arrive incomplete. The bottleneck is not the safety standard. It is the way information is exchanged.
- DIGICAP turns documents into structured, machine-readable data: from individual files to a data-driven process.
- A common digital language for conformity assessment: a harmonised process, standardised data and an open-source framework that anyone can adopt and improve.
- Structured once, reusable across European systems: documents become a structured dossier that is readable, checkable and reusable by Notified Body tools, EUDAMED and RegTech software.
- Tested in real-world pilots: at least 4 pilots with manufacturers and Notified Bodies. Project targets: 60% of applications complete on first submission, 25% fewer requests for missing information and 3-6 months earlier access for patients.
- 19 partners in 13 countries, including 11 Notified Bodies, coordinated by TEAM-NB.
- Join the Stakeholder Panel at digicap.eu. Funded by the European Union.
Why it matters
Europe's medical device approvals are still too document-driven
Every device must prove safety and performance before reaching patients. But under MDR and IVDR, certification has become slower, harder to predict and especially burdensome for SMEs.
The bottleneck is not the safety standard. It is the exchange layer: PDFs, Word files and spreadsheets moving through manual review, local formats and repeated back-and-forth.
More than half of applications arrive incomplete and trigger new review cycles.
Small and medium-sized companies can struggle to find capacity for their dossier.
Objective
Replacing complex document-driven processes with data-driven structured templates
What DIGICAP delivers
A common digital language for conformity assessment
DIGICAP turns technical documentation into structured, machine-readable data that manufacturers, Notified Bodies, software providers and EUDAMED-aligned systems can exchange consistently.
Harmonised process
Clearly defined steps, inputs and outputs from initial contact through post-market surveillance.
Standardised data
Open exchange formats and shared field definitions that reduce reformatting and ambiguity.
Open source
A public framework designed for adoption, improvement and interoperable tooling across Europe.
Documents
PDF · Word · Excel
Structured dossier
Readable · Checkable · Reusable
European systems
NB tools · EUDAMED · RegTech
Who benefits
Less friction for the people moving safe innovation forward
Fewer surprises before submission
Automated completeness checks can catch missing information instantly, reducing costly clarification loops and helping SMEs prepare stronger dossiers.
Comparable dossiers, clearer review paths
Shared data definitions make review inputs easier to compare, validate and route without lowering the safety bar that protects patients.
A market for interoperable tools
Open specifications create a common playing field for RegTech vendors, including AI assistants that support documentation preparation.
Proof in the real world
Pilots will test the framework against concrete performance targets
At least four pilot tests will run with real manufacturers and certifying bodies across medical devices, in-vitro diagnostics and medical device software.
The consortium
19 partners spanning the entire certification value chain
Coordinated by TEAM-NB, DIGICAP brings together Notified Bodies, MedTech Europe, research and technical organisations, legal and public health expertise, and project management support.
TEAM-NB
European Association of Medical Devices Notified Bodies.
Across Europe
13 countries, one framework
- Austria
- Belgium
- Cyprus
- France
- Germany
- Greece
- Ireland
- Italy
- Netherlands
- Norway
- Slovenia
- Spain
- Sweden
With the support of all TEAM-NB members
Project at a glance
A Horizon Europe Coordination and Support Action
- Full name
- DIGItalisation of the Conformity Assessment Process
- Programme
- Horizon Europe · HORIZON-HLTH-2025-01-IND-02
- Grant
- EUR 3,998,062 · Grant Agreement 101288338
- Timeline
- 1 September 2026 - 31 August 2029
- Action type
- Coordination and Support Action
- Open access
- Main results published through the project website and GitHub.
Specific objectives
-
O1
Co-develop a consensus framework describing a digital conformity assessment pathway and evaluate this with the relevant stakeholders, including NBs, MFs and regtech software vendors.
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O2
Propose a set of open-source standardised data schemas and ontologies to support interoperability across CAP tools/software modules.
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O3
Draw a scalable digitalisation roadmap that has reached a high level of agreement and adherence across the ecosystem stakeholders.
Co-create the framework
Join the Stakeholder Panel
DIGICAP will involve 30 to 35 external experts, including manufacturers, software vendors, regulators and public health specialists, through a structured consensus-building process.
What it means to become part of our stakeholder panel
The project has a strong focus on consensus-building through its Stakeholder Engagement Programme, involving representatives from all key stakeholder groups of the MDR/IVDR ecosystem, beyond the Consortium members. Our methodology combines iterative technical advancements by the Consortium's Task Force, with a Delphi methodology to gather and conciliate feedback from the Stakeholder Panel and the strategic Advisory Board. This approach will ensure an inclusive and transparent development of the DIGICAP digitalisation framework, with contributions from different perspectives.
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