The UDI code

The UDI code is a global identification system for medical devices. It improves the quality of care, patient safety and business processes of healthcare providers. In addition, this code reduces the risk of medical device counterfeiting. And recalls of defective products are faster.

When is a UDI code necessary?

Medical devices can be divided into several classes: class I, II and III. For devices in the highest class (III), the deadline for a UDI code already passed on May 2021. Deadlines for medical devices in class II and I follow in 2023 and 2025. For all devices, regardless of risk class, a UDI must already have been assigned as of May 2021. This must match the corresponding article data recorded in the European Database on Medical Devices (EUDAMED).

What does the UDI look like?

The UDI is a unique numeric or alphanumeric code and consists of two parts:

1. Device Identifier (DI): this is a uniform item code. It is a mandatory part that uniquely identifies the device. This unique product number is the Global Trade Item Number (GTIN).
2. Productie Identifier (PI): 2. Production Identifier (PI): this represents all information related to the production process. This is a variable component of the UDI that is added to the code only for high-risk products. The PI contains only data that is written on the label: Lot/batch number, expiration date & serial number.

eCoMET , Besco's unique solution

The vast majority of hospitals track implants and medical devices on paper or via self-applied stickers. eCoMET. eCoMET is the only database software package that links the used medical device, the notification code and the UDI (= GTIN) code
Many expect EUDAMED to provide a solution. Nothing could be further from the truth, this European database will not contain any link between the UDI code and the notification code.

So do you as a hospital want to be ready in time for the change? Then we would be happy to come and give you a demo of eCoMET.

The main provisions of the legislation can be found below:

Medical Devices Act following European Regulation 2017/745

CHAPTER 3. – Identification and traceability of devices, registration of devices and of economic operators, summary of safety and clinical performance, European database on medical devices

Section 1. - Unique Device Identification system

Art. 16. § 1. In accordance with Article 27(9) of Regulation 2017/745, healthcare institutions, must store and retain the UDI of implantable devices delivered to them, preferably by electronic means. § 2. Healthcare practitioners must store and retain the UDI of implantable devices delivered to them, preferably by electronic means.

CHAPTER 9. - Entry into force
Art. 113. § 1. This law shall enter into force on May 26, 2021.
2. Notwithstanding paragraph 1, Article 16 shall enter into force on May 26, 2023.