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Unique Device Identification System

EU Medical Device Regulations 2017/745 and 2017/746

Two new Regulations – EU MDR 2017/745 on medical devices and IVDR 2017/746 were adopted in April 2017 and came into implementation on 25 May 2017.

Regulations 2017/745 and 2017/746 introduce the requirement of Unique Device Identifier for Medical Devices in EU. The UDI system is explained in detail in Part C of Annex VI of the EU Medical Device Regulation.

The aim of introducing is easier traceability of medical devices, to enforce a more structured and systemic approach for the post-market safety-related activities for devices and robust monitoring by the competent authorities. UDI implementation will also help in the reduction of medical errors and identification of falsified medical devices. The UDI system is applicable for all medical devices except the custom made and performance study/investigational devices.

Basic UDI-DI

The Basic UDI-DI is the primary identifier of a medical device model and the main key to link information in the EUDAMED database and relevant documentation (e.g. certificates, declaration of conformity, technical documentation and summary of safety and clinical performance) with the device model.

It is intended to identify and connect devices with the same intended purpose, risk class and essential design and manufacturing characteristics.

A Basic UDI-DI identifies a group or “family” of medical devices that all bear the same core characteristics, i.e. intended purpose, risk class, essential design. It consists of a series of numeric or alphanumeric characters. It is independent/separate from the packaging/labelling of the device and it does not appear on any trade item.

The Basic UDI-DI is assigned through a globally accepted device identification and coding standard and delivered by an accredited issuing agency.

UDI-DI

The intent of this is the identification of a product within a product group.

The UDI-DI is a unique numeric or alphanumeric code for identifying a specific medical device within the product family.

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, CMR/Endocrine disruptive, colour, language.

Note: Higher UDI-DIs are linked to the Basic UDI-DI meaning there is one Basic UDI for many UDI-DI.

UDI-PI

The UDI-PI means Unique Device Identification- Product Identifier. It is a numeric or alphanumeric code that identifies the unit of device production or batch.

The different types of UDI-PIs include serial number, lot number, software identification and manufacturing date and/or expiry date. The UDI-PI characteristics such as the lot or serial number shall be defined by the manufacturer.

For active implantable devices, serial numbers on unit level are required. However, for other implantable devices, serial number or lot number meets the requirement.

A configurable device UDI-PI shall be assigned to each individual configurable device.

UDI Issuing Agencies

On 06th Jun 2019, the following organizations have been designated as UDI issuing agencies:

GS1 AISBL 

Health Industry Business Communications Council (HIBCC)

International Council for Commonality in Blood Banking Automation (ICCBBA)

InformationsstellefürArzneispezialitäten — IFA GmbH

The UDI Carrier

The UDI Carrier [Automated Identification for Data Capture (AIDC) and human-readable interpretation (HRI) representation of the UDI] shall be on the label or on the device itself and on all higher levels of device packaging. UDI carrier is a way, the UDI code is visible to us.

Reference:

  1. Unique Device Identification (UDI) System - FAQ
  2. https://ec.europa.eu/docsroom/documents/31924
  3. https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32017R0745&from=EN
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