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EU MedTech Initiative
For IVD Medical Devices Pharma

EU initiative, providing
the automation infrastructure for

An EU initiative building the software infrastructure that lets manufacturers reduce manual work, compete globally, and operate with confidence — in a validated, regulatory-native environment.

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Research & development supported by
Research & development supported by
Trusted by globally active manufacturers
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EU Industry Initiative

Strengthening the innovation capacity of European manufacturers.

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50%
of regulatory work is repetitive, manual documentation.
Research & development supported by

The problem

European manufacturers
are under structural pressure.

To stay at the forefront, manufacturers need to move fast. The current regulatory documentation infrastructure makes that structurally impossible — and the numbers show what happens when it doesn't change.

01 — Approval failure
40%
of initial EU approval applications fail on the first attempt
Documentation gaps, inconsistent cross-references, missing traceability.
Rework, delay, and cost
02 — Time to market
18mo
average time for an EU approval — twice as long as before MDR
Same processes and tools, against requirements that doubled in scope.
Lost time-to-market
03 — Market withdrawal
50%
of EU manufacturers deprioritise Europe for new approvals
Documentation burden is reshaping where products launch first.
Reduced patient access
04 — Portfolio reduction
33%
of EU manufacturers are actively shrinking their EU portfolio
Devices withdrawn — not for safety reasons, but documentation cost.
Supply risk across Europe

Sources: MedTech Europe Facts & Figures 2025 · European Commission Monitoring Report · MedTech Europe MDR/IVDR Leaflet 2025

Our response

The intelligence infrastructure for technical documentation.

Explore the technology

The manufacturers who will define European MedTech over the next decade are the ones building on modern infrastructure today — moving faster through approvals, entering new markets with less friction, and operating with the kind of traceability that regulators and partners expect.

Use cases

Solutions built with manufacturers.
For manufacturers.

Use Case 01
Automated Technical Documentation
Recurring regulatory content managed at the database level. One change propagates automatically across every linked document — no manual updates, no out-of-sync files.
500+ redundant entries automated per TD
See use case →
Use Case 02
NB Submission Readiness
Every open item — missing section, outdated reference, pending sign-off — tracked inside the document. One structured submission package, ready before it leaves the team.
40% reduction in submission preparation time
See use case →
Use Case 03
Multi-Market Registration
Branch your technical file per jurisdiction. Manage only the differences. Core changes propagate to all markets automatically — no parallel files, no manual reconciliation.
120+ countries and jurisdictions supported
See use case →
Use Case 04
Change Control & Consistency
Confideck traverses structural content relationships — identifying every affected document, clause, and cross-reference across the entire technical file automatically.
0 missed dependencies at audit
See use case →
Use Case 05
Document Lifecycle & eSignatures
From draft to approval, release, and archival — Confideck gives regulatory teams complete lifecycle control with FDA 21 CFR Part 11 compliant eSignatures built in.
5min average document approval cycle
See use case →
Use Case 06
AI Compliance & Gap Detection
Semantic analysis across the entire technical file. Content gaps, contradictions between documents, and outdated standards surfaced — before submission, not during NB review.
0 known gaps entering NB review
See use case →
Talk to us
See how it applies
to your product category.
30 minutes. We walk through a live documentation environment matched to your regulatory context.
Start the conversation →

Talk to our initiators

Be among the manufacturers
who move now.

We work directly with manufacturers — bringing real workflows, real documents, and real compliance environments into the development process. You don't just use the infrastructure. You help shape it.

Schedule a conversation
Discover
Confideck.

A 30-minute call with our initiators — directly. No sales process. We talk through your regulatory environment, where documentation is slowing you down, and whether Confideck makes sense for your organisation.

Start the conversation

No commitment required. Just a conversation between people who care about the same problem.