About the project
About DIGICAP
An open, harmonised digital framework for medical device certification in Europe.
Why this matters
Every medical device sold in Europe — from a heart valve to a diabetes test strip — must first be certified as safe and effective. Since the EU Medical Device and In-Vitro Diagnostic Regulations took effect in 2021 and 2022, that certification now takes 13–18 months on average, and often 22 months or more for complex devices. Between 15% and 30% of small and medium-sized manufacturers cannot even find a Notified Body able to take on their dossier.
The bottleneck is not the safety review itself — it is the plumbing underneath it. Today’s process runs on PDFs, Word files and emails. Every Notified Body uses its own format, so the same information is repackaged again and again, and more than 50% of applications arrive incomplete. European patients wait longer for innovative devices, and European SMEs — 90% of the industry — lose ground to international rivals. Nearly half of new products are now launched outside the EU first.
What DIGICAP does
DIGICAP — DIGItalisation of the Conformity Assessment Process — designs and tests a common digital framework for medical device certification across Europe. Instead of exchanging documents, manufacturers and Notified Bodies exchange structured data that computers can read, check and validate automatically. The framework rests on three principles:
- Harmonised process. Clearly defined steps from initial contact to post-market surveillance, with explicit inputs and outputs at each stage.
- Standardised data formats. Open, machine-readable specifications so any tool can talk to any other tool — and connect to EUDAMED, the official European medical devices database.
- Open source. The framework will live in a public GitHub repository, free for anyone to use, adapt and improve.
The shift from documents to data unlocks three wins: speed, because automated checks catch missing information instantly; predictability, because everyone works from the same fields and definitions; and innovation, because software vendors — including AI tooling providers — can build on a shared, open standard.
How we’ll prove it works
Designing a framework is one thing; proving it works in the real world is another. DIGICAP will run at least 4 pilot tests with real manufacturers and Notified Bodies, covering medical devices, in-vitro diagnostics and medical device software. At least 80% of the participating manufacturers will be SMEs — the group with the most to gain. Pilots run in parallel to official certification, so no one’s real-world approval is at risk.
Success will be measured against concrete targets:
- 60% of applications complete on first submission — today, only one in four reaches even 50% completeness.
- 25% fewer back-and-forth requests for missing information.
- 20% shorter processing times for the steps tested.
The consortium
DIGICAP brings together 19 partners across Europe, coordinated by TEAM-NB, the European Association of Medical Devices Notified Bodies, whose members issued around 85% of all European certificates in 2024. The consortium covers the full value chain: 11 Notified Bodies from 10 countries (a balanced mix of public and private, large and small), alongside MedTech Europe (the voice of the European medical technology industry), VITO (Belgium, vendor-neutral technical leadership), RISE (Sweden, European Reference Laboratory), AXON Lawyers (Netherlands, medical device law), EUPHA (the European Public Health Association), MDKU (Germany, shared data model for technical documentation) and MATICAL (Spain, supporting the coordinator on project management and stakeholder engagement). A Stakeholder Panel of 30 to 35 external experts will co-create the framework throughout the project. See the full consortium →
