Harmonised process
Clearly defined steps from initial contact to post-market surveillance, with explicit inputs and outputs at each stage.
DIGICAP · Horizon Europe
From documents to data
An open, harmonised digital framework for medical device certification in Europe — replacing emailed PDFs with structured, machine-readable data that flows automatically between manufacturers, Notified Bodies and EUDAMED.
By the numbers
Today's bottleneck — and where we aim to be
Today
13–18
months Current EU certification time, up from 7–9 before MDR.
DIGICAP target
0%
first-submission completeness Today only 1 in 4 applications reach 50% completeness.
DIGICAP target
0%
back-and-forth requests Automated checks catch gaps before submission.
DIGICAP target
0%
shorter processing time Measured across the certification steps in pilot scope.
DIGICAP delivers
A common digital language
…between manufacturers, Notified Bodies and EUDAMED.
Standardised data
Open, machine-readable specifications so any tool can talk to any other tool and connect to EUDAMED.
Open source
The framework lives in a public GitHub repository — free for anyone to use, adapt and improve.
The consortium
19 organisations across Europe
Coordinated by TEAM-NB · 11 Notified Bodies from 10 countries · MedTech Europe · research and policy partners.
TEAM-NB
CoordinatorBSI
BeneficiaryCERTIQUALITY
BeneficiaryDNV
BeneficiaryEKAPTY
BeneficiaryGMED
BeneficiaryHTCert
BeneficiaryNSAI
BeneficiaryQMD
BeneficiarySIQ Ljubljana
BeneficiaryLatest news
What's happening
DIGICAP opens call for pilot participants
DIGICAP is recruiting manufacturers and Notified Bodies for at least four pilots that will test the framework end-to-end, with at least 80% SME participation.
Stakeholder requirements report (D2.1) delivered
The first DIGICAP deliverable, consolidating stakeholder requirements for the digital certification framework, has been submitted to the European Commission.
DIGICAP at the European MedTech Forum 2026
The coordinator presented DIGICAP's approach to digital certification at the European MedTech Forum, alongside MedTech Europe and Notified Body representatives.
Upcoming events
Where to meet DIGICAP
DIGICAP framework: overview webinar for SMEs
Online introduction for SME manufacturers on how DIGICAP will move medical device certification from documents to structured data.
Stakeholder Panel: first Delphi workshop
In-person Delphi workshop with the DIGICAP Stakeholder Panel to consolidate the first round of feedback on the draft data model.
From documents to data: DIGICAP at MedTech Summit 2026
Hybrid conference talk presenting DIGICAP's progress on digital certification, with live audience in Amsterdam and an online stream.