The importance of 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 limits the risk of counterfeit medical devices. And recalls of defective products are carried out more quickly.

When is a UDI code necessary?

Medical devices can be divided into different classes: class I, II and III. For devices in the highest class (III), the deadline for a UDI code has already passed on May 2021. The deadlines for medical devices from classes II and I will follow in 2023 and 2025. For all devices, regardless of the risk class, a UDI must already have been assigned from May 2021. This must correspond to the associated article data recorded in the European database for medical devices (EUDAMED).

What does the UDI look like?

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

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

Deze fotoblock module heeft nog geen inhoud

eCoMET, the unique solution from Besco

The vast majority of hospitals track implants and medical devices on paper or via self-adhesive stickers. eCoMET is the only software package with a database that makes a link between the medical device used, 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 if you want to be ready for the change in time as a hospital, we would be happy to give a demo of eCoMET.

The most important 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 economic operators, summary of safety and clinical performance and European databases for medical devices

Art. 16. § 1. In accordance with Article 27, paragraph 9, of Regulation 2017/745, healthcare institutions must store and keep, preferably by electronic means, the UDI of the implantable devices supplied to them.

§ 2. Healthcare professionals must store and keep the UDI of the implantable devices supplied to them, preferably by electronic means.

CHAPTER 9. – Entry into force
Art. 113. § 1. This Act shall enter into force on 26 May 2021.
§ 2. By way of exception to paragraph 1, Article 16 shall enter into force on 26 May 2023.

The importance of the UDI code

When is a UDI code necessary?

What does the UDI look like?

eCoMET, the unique solution from Besco

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