Get UDI Compliance, Fast, Easy, and Affordable
EasyUDI, the lightweight solution for all medical device manufacturers, be 100% ready for EU MDR 2017/745 and IVDR 2027/746.
The Deadline Has Passed: Are You UDI Compliant Yet?
As of May 26, 2025 , manufacturers of medical devices must have the UDI carrier (e.g., barcode) affixed to the device label and all higher levels of packaging (excluding shipping containers), in accordance with Article 27(4).
If you're not compliant, you're already at risk of non-compliance penalties.
Act now before it impacts your business.
Non-Compliance Costs You More Than You Think
Blocked shipments to the EU market
Fines from national authorities
Loss of CE marking eligibility
Instantly Create and Manage UDI Labels, Without the Headaches
Generate Batch Labels
Easily create large batches of serialized labels that meet GS1 standards, EU MDR 2017/745 and IVDR 2027/746 requirements.
Barcode Compliance
We handle GS1-128 and GS1 DataMatrix barcode marking for you, ensuring full compliance and accuracy.
Compliant & Secure
Your UDI holders are produced according to GS1 standards and meet the requirements of EU MDR/IVDR and EUDAMED
Our Plans
Starter
Guided Compliance
- Occasional human support
- Flash initial diagnostic
- Training
- All-in-one business tools (EasyUDI)
- compliant UDI generator (GS1 issuing entity)
- UDI labeling
- EUDAMED transmission
- Email Support
Pro
Driven Compliance
- Everything in UDI Generator +
- Continuous human support
- Advanced diagnostic
- EUDAMED update
- GS1 update
- Multi-language UDI data
- Complex catalogs
- Declaration of Conformity (DoC) Template
- Audit Trail (traceability)
- Email/Chat/Phone Support
Enterprise
Total Excellence
- Everything in Pro +
- Dedicated support
- In-depth diagnostic
- Custom structuring
- Document manager
- ERP connector
- Multi-SRN
- Multiple databases
- 24/7 Priority Support
The true story of your products on EUDAMED
⚠️ Compliance mandatory by May 26, 2025 under Regulation 2017/745
Do you want a simpler and faster solution to obtain unique device identifiers (UDI) from your GTIN with regulatory labels, without handling GS1 and EUDAMED details daily?
EasyUDI, the compliance tool built by and for medical device manufacturers seeking simplicity. Our turnkey UDI management system and rapid label printing let you meet regulatory UDI requirements without technical complexity or excessive costs.
We support you in your UDI implementation project, zero UDI knowledge required, GS1 and EUDAMED compliance guaranteed!
EasyUDI in action!
Your UDIs in just 3 simple steps!
Import production file
You upload your day’s builds (Excel/ERP).
UDI should not be a barrier.
We make it simple and fast for you.
We manage the GS1/EUDAMED validation rules, you avoid the hassle.
Your medical devices are edited according to EUDAMED expectations.
We handle GS1-128 and GS1 DataMatrix codes for you.
Our clients testify
They talk about it better than we do
FAQ
FAQ - Frequently Asked Questions
EUDAMED, the European Database on Medical Devices, is the EU-wide database for medical devices.
It is the responsibility of competent authorities, notified bodies, manufacturers, importers, and authorized representatives to enter and maintain information in EUDAMED.
The Regulation (EU) 2017/745 on medical devices (MDR) mandates UDI compliance for class I devices starting May 26, 2025.
This deadline concerns the implementation of UDI marking on the labels of class I devices.
No, we’re here to guide you.
We also offer training and consulting services on the topic.
UDI ensures traceability of medical devices and allows them to be marketed.
It guarantees compliance with current regulatory requirements.
Non-compliance can result in sanctions or blocked products.
Yes, if you manufacture medical devices.
UDI labeling on device packaging becomes mandatory starting May 26, 2025.
This includes manufacturers of lenses and optical frames, orthopedic insoles, optical materials and instruments, patient lifts, wheelchairs, crutches, thermometers, dressings, syringes (without needles), scalpels, ECG electrodes, exam gloves, surgical masks, sutures, dental floss, and more.
You are not affected if your devices are custom-made.
With us, compliance becomes simple! We are experts in end-to-end traceability for regulated products.
In addition to managing your UDI, we provide a digital passport that connects your products directly to your customers.
Simple, efficient, and 100% secure.
UDI (Unique Device Identification) is a global code that uniquely identifies medical devices.
Each product must have a unique identifier on its label, both human-readable and machine-readable, linked to a regulated database like EUDAMED.
In EUDAMED and in GS1-128 / GS1 DataMatrix barcodes, the GTIN (Global Trade Item Number) is extended to 14 digits (by adding a leading zero) to meet UDI requirements.
A UDI consists of two parts.
The first is a static part corresponding to the unique identifier of the device (DI), based on the GS1 GTIN.
The second is a dynamic part containing one or more production identifiers (PI), such as the expiration date, manufacturing date, lot number, or serial number.
Each PI is preceded by an Application Identifier (AI) that specifies the data type (e.g., (11) for manufacturing date, (10) for lot number, etc.).
The UDI must appear directly on the medical device when possible, or on its packaging.
It must be shown in at least two forms: human-readable and machine-readable (barcode).
That’s correct. It’s an access key for EUDAMED.
The Basic UDI-DI (BUDI-DI) is only required to identify a model or a family of devices.
It allows grouping multiple products under a single registration.
It’s free to create and can easily be generated using GS1’s GMN tool.
The Master UDI-DI is a unique identifier used to group highly individualized devices (especially in optics) that share similar characteristics.
This helps reduce the number of entries in EUDAMED.
It currently applies to contact lenses, eyeglass lenses, frames, and over-the-counter reading glasses.
EUDAMED Resources
Discover our comprehensive guides to understand EUDAMED and succeed with your registration before the May 28, 2026 deadline
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