What Does the UDI System for Medical Devices Entail?

27 Apr 2021

In April 2020, the European Union delayed the coming into effect of Regulation 2017/745 on medical devices and Regulation 2017/746 on in vitro diagnostic medical devices because of the situation caused by the COVID-19 pandemic. A year later, the implementation of these regulations, which demand the use of the UDI system in medical devices, will soon be a reality, to be precise, from this coming 26th of May.

What does UDI or ‘Unique Device Identification’ mean?

UDI stands for ‘Unique Device Identification’, and it is a codification system that enables the identification and tracking of healthcare products along with the entire supply and usage chain.

This unique alphanumeric code is divided into two parts:

- Device Identifier (DI): this is a fixed part, which identifies the manufacturer and the specific medical device model.

- Production Identifier (PI): this part is dynamic, or variable, since it identifies one or several facts about each product (batch number, serial number, expiration date, manufacturing date).

How does the UDI system for medical devices work?

Manufacturers must assign a UDI code to each healthcare product they release to the market. This must appear on the packaging, and, in the case of reusable devices, on the product itself. There must also be a symbol or a data carrier that can be read or scanned in order to access the information. Line barcodes or Data Matrix codes (in the case of small-sized folding cartons) are the ones most commonly used.

On the other hand, the UDI system is backed by a specific database whose purpose is to verify the information for healthcare organisations, healthcare professionals and any economic operators. In the EU, the database for the UDI system is part of the EUDAMED, and it works as an interconnecting platform for the different actors involved in the process, as is explained in the following diagram:

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Moreover, in the EU, manufacturers must generate and assign an additional code known as Basic UDI-DI. This is the primary identifier that is used in the EUDAMED database and in the relevant documentation of the healthcare product (certificates, technical documentation, etc).

The Basic UDI-DI code is used to classify the medical devices in groups and to make easier the access to information concerning the intended purpose, risk class and its manufacturing characteristics. Basic UDI-DI is not on the product or on the medical device’s packaging. 

What medical devices are affected by the UDI system?

We understand medical devices as any instrument, piece of equipment, material, device or software tool that has been designed by the manufacturer to be used as a means of diagnosis, prevention, control, treatment or relief for people suffering from an illness, injury or deficiency. They can also be used in the context of research, anatomical modification or substitution, or a physiological process.

There are different types of medical devices whose packaging will have to count with the UDI codification:

Class I. Low risk: non-invasive products such as bandages, compression tights, urine drainage bags, among others.

Class Is. Low risk: non-invasive products that have special features, for instance, because they have been sterilised or because they have a measuring purpose. In the case of glasses, examination gloves, syringes, non-electronic thermometers, dressings to protect wounds, etc.

Class IIa. Middle risk: this refers to invasive short-term medical devices such as needles, contact lenses, cannulae, lancets, surgical gloves, etc.

Class IIb. High risk: these products are invasive medical devices that are used in surgical procedures with long-term results. Some of them can be implanted, such as intraocular lenses. 

Class III. High risk: devices that are implanted for active use such as stents, catheters, absorbable sutures, etc.

The UDI system for medical devices will come into effect in the EU shortly

According to the European Commission’s guide, the implementation of Regulations 2017/745 and 2017/746 is imminent for several medical devices:

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As packaging providers for the pharmaceutical industry, at Essentra we can help you, should you need to adjust the folding cartons of your medical devices to the new European UDI system. Contact us here and our specialists will study how to best adapt secondary packaging to the new regulations.