UDI TRACEABILITY FOR EU IMPORTERS & DISTRIBUTORS
Trace every medical device.
Prove every movement.
UDIFlow is a digital tool for traceability of medical devices and IVDs, designed exclusively for importers and distributors in the EU. It meets your obligations under Article 25 of the MDR and Article 22 of the IVDR.
UDIFlow connects UDI-DI/UDI-PI, receipts, deliveries, inventory, quarantine, complaints and recalls in one controlled workspace.
Supports a regulatory compliance role that ensures compliance and traceability. It’s first simple tool in your daily practise for tracking medical devices.
Control-ready history MDR/IVDR traceability workflows GS1 – HIBCC – IFA – ICCBBA
Built for regulated medical-device distribution
end-to-end
control
access
A simple process. Full traceability.
Serialize
Apply UDI to products
Track
Capture movements
across your supply chain
Distribute
Ship with confidence
Stay compliant
Be revision and recall ready
What UDIFlow solves
UDI / PI / DI management
Maintain hierarchies
and master data
Execution and
traceability
Capture and trace movements
across your supply chain
Regulatory &
MDR / IVDR compliance
Structured data for
regulatory obligations
Complaints, vigilance
and recalls
Manage incidents,
complaints and recalls
Reporting
and analytics
Revision-ready reports
and KPIs
Role-based security
and traceability
Complete revision trails
with granular access
Separates accounting
Separation of economic operations
from regulatory obligations
UDI code check
Helps identify invalid
or suspicous UDI codes
Execution and
traceability
Capture and trace movements
across your supply chain
Stock management
Manage stock in
your warehouses
Designed around MDR/IVDR traceability workflows.
UDIFlow is designed to support importers and distributors in meeting the traceability requirements set out in Article 25 of the MDR and Article 22 of the IVDR. It connects suppliers, devices, UDI-DI / UDI-PI data, deliveries, customers and related records in one structured traceability system.
for a safer tomorrow.”
Better preparedness.
UDI TRACEABILITY
Know the device. Follow its path.
Connect device identification with everyday inventory work.
MDR · ARTICLE 27 / IVDR · ARTICLE 24
UDI-based identification
Link UDI-DI and UDI-PI with lots, serial numbers, stock movements and deliveries. Find the relevant device records quickly.
products
to people.
Traceability
builds trust.
ERP tracks transactions.
UDIFlow tracks regulatory traceability.
- ✓ Sales documents
- ✓ Accounting records
- ✓ Stock quantities
- × Regulatory UDI traceability
- × Linked UDI-DI / UDI-PI data
- × Recall-ready traceability
- × Vigilance workflow
- ✓ UDI-DI / UDI-PI
- ✓ Lots & serials
- ✓ Customer traceability
- ✓ Quarantine management
- ✓ Vigilance and complaints
- ✓ Recalls
- ✓ Revision-ready evidence export
Built for accountability
Every essential change can be traced back to its source.
UDIFlow records events, associated document, user and time for receipts, issues; movements between warehouses, quarantine.
Did you know?
As a distributor and importer you are obliged to ensure traceability for all devices that you place on the EU market and make available on the EU market?
100+
Satisfied Customers
25+
Years of
Experience
Best Medical Device Tracking Solution That You Can Trust
Originally developed for our own use, the app combines Dr. Rodič’s experience as a physician and medical device manufacturer with Ms. Podboršek’s regulatory expertise of the ecosystem in the European union, backed by their shared experience in medical device regulation. We have knowledge which ensures you to be compliant with legislation.
MDR & Regulatory Expertise
Quality Management Systems Expertise
Medical Device Manufacturing Expertise
Built on Real-World Experience
+386 xx-xxx-xxx
Do You Have Any Question?
Why did we create the app?
- Accounting documents do not enable traceability,
- ERP systems do not know UDI-DI/UDI-PI,
- Delivery notes do not contain regulatory data,
- Vigilance and recalls require immediate information,
- Traceability is legally mandatory for all importers/distributors,
- UDI will/is mandatory on all devices,
- We wanted a simple one-stop solution – even for Class III implantable devices.
- This is why we wanted to create the first specialized solution in the EU designed exclusively for the traceability of medical devices and IVDs under Article 25 of the MDR/IVDR, specifically for importers and distributors.
Frequently Asked Questions
Explore Our Testimonials
Read testimonials from our users.
UDIFlow has made our device tracking much simpler and more reliable. We now have a clear overview of products, batches, deliveries and traceability records in one place, which saves us a considerable amount of administrative work. A simple solution for meeting regulatory obligations and efficiently implementing recalls.
Tone B.
Administrator
What we value most about UDIFlow is that it was clearly designed with real medical device workflows in mind. It helps us maintain structured records, improves traceability and makes regulatory and quality-related tasks much easier to manage.
Iris P.
Management representative
DID YOU KNOW?
- UDIFlow is the first specialized solution in the EU designed exclusively for the traceability of medical devices and IVDs under Article 25 of the MDR/IVDR, specifically for importers and distributors.
- UDIFlow is a specialized system for the digital traceability of medical devices and IVDs for importers and distributors, designed to support MDR/IVDR requirements.
- UDIFlow is a solution that enables importers and distributors to implement and document medical device and IVD traceability in a demonstrable manner in accordance with MDR/IVDR requirements.