An Overview of European Unique Device Identification System

Device Identification (UDI) system designed to uniquely and consistently identify medical devices throughout the global supply chain. The core elements of the system are defined in Articles 27–31, Chapter III, and Annex VI of the regulations, with additional guidance expected from EU authorities. 

The UDI system applies to all medical devices except custom-made devices and those intended solely for performance studies or investigations. It is aligned with internationally recognized standards and harmonized definitions used by major regulatory partners.

Basic UDI-DI

The regulations introduce the “Basic UDI-DI,” a numeric or alphanumeric code used to group devices that share the same intended purpose, risk class, and essential design and manufacturing characteristics. 

Key points include:

• It acts as the primary access key to device information in EUDAMED. 
• It must be referenced in certificates, declarations of conformity, technical documentation, and summary of safety and clinical performance documents. 
• It links devices within the same family but does not appear on labels, packaging, or any trade items. 
• Each Basic UDI-DI must uniquely identify the entire device group it represents.

What Is the Unique Device Identification (UDI)?

The UDI system, described in Part C of Annex VI of the EU MDR, consists of a globally standardized series of characters enabling precise identification of a specific device. The UDI on the device comprises two elements:

• Device Identifier (UDI-DI): The UDI-DI is a unique numeric or alphanumeric code that identifies a specific medical device within the product ‘family’. As per Part B of Annex VI of the EU MDR, a new UDI-DI required in case of a change of name/trade name, version/model, use, sterilization requirements, change of quantity in packaging, new indications/warnings. Higher UDI-DIs are linked to the “Basic UDI-DI”; for example, single pack and six pack would have a different UDI-DI but the same “Basic UDI-DI”, same devices but in different language packaging would each have their own UDI-DI, etc.
• Production Identifier (UDI-PI): The UDI-PI that identifies the unit of device production and if applicable the packaged devices, as specified in Part C of Annex VI of the EU MDR. The UDI-PI contains a variable code related to production data of the device, such as lot/batch number, expiry date, manufacturing date, etc.

UDI Carrier

According to the EU MDR, the UDI carrier must be placed on the device label or packaging and all higher levels of packaging (excluding shipping containers). This requirement does not imply aggregation, as parent–child packaging relationships are not mandatory. 

Reusable devices must have the UDI carrier directly on the device, and implant device UDIs must be visible before implantation.

Acceptable machine-readable formats include:

• Linear barcode (concatenated or non-concatenated) 
• Data matrix 
• RFID (with an additional printed barcode required) 

Deadlines for EUDAMED UDI Registration

Mandatory UDI data submission deadlines:

• Medical devices: 26 November 2021 
• In vitro diagnostic devices: 26 November 2023 

These apply only if EUDAMED is fully functional by the date of application; otherwise, deadlines shift to 24 months after functionality becomes available.

Voluntary early registration:

• Medical devices: from 26 May 2020 
• IVDs: from 26 May 2022 

Once EUDAMED becomes fully functional, device registration (per Article 29 of MDR and Article 26 of IVDR) is required before reporting any serious incidents involving those devices in EUDAMED.stic medical devices, the full registration of devices (Article 29 of MDR and Article 26 of IVDR) remains a pre-condition for the possible registration of their relevant serious incident in EUDAMED.