If you manage a medical practice, a pharmacy, a dental office, or a polyclinic, you have a legal obligation regarding the medical devices you receive and use: to record and store their Unique Device Identification (UDI) in electronic format.
This is not a future requirement. It is an obligation already in effect since January 15, 2024, and those who do not comply risk an administrative fine of up to 24,500 euros. With the European database EUDAMED becoming fully operational during 2026, focus on the entire traceability chain—including inspections—is set to increase.
This guide brings together everything you need to know: what the UDI is, who is obligated, which devices are included, deadlines, penalties, and how to become compliant without complicating your life.
What is the UDI
The UDI (Unique Device Identification) is an alphanumeric code that uniquely identifies a medical device. It serves to track every device throughout the entire supply chain—from the manufacturer to the patient—so that, in the event of a recall or incident, it is possible to trace exactly which products and which patients are involved.
The code consists of two parts: one that identifies the device model and one that collects traceability information (batch, expiration date, serial number). The manufacturer “translates” it onto the label in the form of a barcode or data matrix.
The UDI system stems from the European Medical Device Regulation (MDR, Reg. EU 2017/745) and is linked to EUDAMED, the European database that centralizes registrations, UDI data, certificates, and vigilance reports for all Member States.
👉 In-depth look: What is the UDI and who is obligated to register it
Who is obligated to register the UDI
In Italy, the obligation arises fromArt. 15 of Legislative Decree 137/2022, which delegated the operational procedures to the Ministry of Health decrees of May 11, 2023.
The obligation concerns health institutions and healthcare professionals—including professionals who do not operate within a health institution. In practice: medical practices, dental offices, pharmacies, polyclinics, associated practices, and multi-specialty centers.
They must record and store the UDI of the devices they have received or provided (implanted).
Which devices fall under the obligation
Not all devices are subject to the obligation. Registration is mandatory for:
- Class III implantable medical devices (provided or received);
- Class IIb implantable medical devices;
- Non-implantable Class III medical devices;
- Class D in vitro diagnostic medical devices (IVD).
For all other devices, registration remains voluntary—but many operators choose to manage it anyway, because having a fully tracked warehouse simplifies vigilance, recalls, and inspections.
👉 In-depth look: Which devices you must register
How to register the UDI: the electronic method
The decrees are explicit on one point: registration and storage must take place electronically. Paper-based management is not compliant.
Furthermore, for implantable devices, information must be stored for at least 15 years and must be available for presentation upon request by supervisory bodies.
This means, in practice, that you need a system that:
- captures the UDI code (ideally automatically, by reading barcodes or data matrices);
- stores data securely and for the required period;
- allows you to present them quickly in the event of an inspection.
👉 In-depth look: How to register and store the UDI in electronic format
Deadlines to know
- January 15, 2024 — the obligation for registration and storage of the UDI for health institutions and healthcare professionals comes into force (decrees of May 11, 2023).
- May 28, 2026 — EUDAMED becomes mandatory for modules declared fully operational.
- November 28, 2026 — end of the six-month transitional period for devices already on the market.
👉 In-depth look: UDI and EUDAMED 2026 deadlines: all the dates
Penalties
Legislative Decree 137/2022 provides for an administrative fine ranging from 4,000 to 24,500 euros for healthcare professionals who do not register UDI codes. This is not a theoretical risk: the obligation is active and inspections of medical devices are becoming increasingly frequent.
👉 In-depth look: UDI penalties: what you really risk
How to make your warehouse compliant with MedStock
MedStock is the cloud software designed exactly for this obligation. It allows you to:
- automatically recognize the UDI by reading barcodes and data matrices (with manual entry when needed);
- store data in the cloud securely and for the period required by law;
- monitor stock levels, with notifications for expiring batches and low stock;
- manage multiple warehouses and multiple users, with transfers between locations.
In other words, it transforms a regulatory obligation into an organized warehouse management system that is always ready for a potential inspection.
➡️ Try MedStock free for 30 days — no commitment, cancel anytime during the trial.
Frequently Asked Questions
Does the UDI obligation apply to my practice? Yes, if you are a healthcare professional or institution and you receive or provide devices in the classes subject to the obligation (implantable IIb, Class III, IVD Class D).
Since when has it been in effect? Since January 15, 2024, as a result of the decrees of May 11, 2023, implementing Legislative Decree 137/2022.
Can I manage the UDI on paper or in an Excel sheet? The regulations require electronic format and storage for at least 15 years for implantables. A dedicated system reduces the risk of errors and non-compliance.
What do I risk if I don’t register? An administrative fine ranging from 4,000 to 24,500 euros.
Do you have doubts about your specific case? Contact us and we will help you understand what is needed for your practice.
