Regulations
A brief summary of UDI regulations
1. The UDI Registration Requirement
The decree (Legislative Decree 11/05/2023) requires healthcare professionals to register and maintain the unique device identifier (UDI) of medical devices received and used (with particular attention to implantable devices and Class D in vitro diagnostic devices). The objective of the law is to ensure complete traceability, from the manufacturer to patient use, to enable prompt intervention in case of defective batches.
2. Data Retention for Up to 15 Years
The law makes no exceptions regarding timeframes: UDI code records (including batches and expiration dates) must be retained for a minimum of 10 years, a period that extends to 15 years for implantable medical devices. Entrusting such a volume of data to paper records or local Excel spreadsheets means exposing oneself to the very high risk of data loss, deterioration, or theft. The legislator itself recommends electronic storage.
3. Fines from €4,000 to €24,500
Non-compliance with these requirements is not taken lightly. As established by the related Legislative Decree 137/2022, failure to register or incorrect registration of UDI codes exposes the healthcare operator or clinic to extremely severe administrative penalties, ranging from €4,000 to €24,500.
How MedStock Ensures Your Compliance (Zero Stress)
Instead of filling out endless manual records with the fear of making errors, MedStock automates the entire regulatory process:
Instant Acquisition: Scan the barcode on the package. MedStock automatically reads and breaks down the UDI code (UDI-DI and UDI-PI).
Secure Cloud Storage: Your data is saved on cloud servers, immune to loss or failure of your local computer, and retained over time in perfect alignment with the 10/15 years required by law.
Ready for Inspections: In case of inspection by the relevant authorities, you only need one click to export and present the entire traceability history required by the Ministry.
UDI Acquisition Timeframes
With the entry into force of the new European regulation EU Medical Device Regulation (EU MDR) on medical device traceability, healthcare operators are required to:
- Verify UDI (Unique Device Identification) labeling on all medical devices used in clinical practice.
- Register and document the UDI of devices used on patients.
The term “medical device” covers a wide range of items, including apparatus and equipment in direct contact with the patient for purposes of diagnosis or treatment of a clinical condition, and therefore includes many instruments commonly used by physicians.
The deadlines for compliance with the MDR regulation on UDI coding of medical devices vary based on the device class, which is determined by the associated risk level.
In particular, Class III devices present a high risk to the patient.
- Class III: includes devices such as implantable pacemakers, pulse generators, HIV diagnostic tests, automated external defibrillators, endosseous implants, and extended-wear contact lenses.
- Class II a/b: includes devices such as acupuncture needles, daily contact lenses, motorized wheelchairs, infusion pumps, surgical drapes, and implantable radiofrequency transponder systems for patient identification and health information.
- Class I: includes low-risk devices such as elastic bandages, latex gloves, and handheld surgical instruments.
| May 5, 2017 | Publication of EU regulation | Medical device coding | Direct marking of medical device | In vitro diagnostic medical device coding |
|---|---|---|---|---|
| May 26, 2020 | UDI assignment and registration on EUDAMED | |||
| May 26, 2021 | Class III MD | |||
| May 26, 2023 | Class II a/b MD | Class III MD | Class D IVD | |
| May 26, 2025 | Class I MD | Class II a/b MD | Class C&B IVD | |
| May 26, 2027 | Class I MD | Class A IVD |
