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Unique Device Identification System
EU MDR and IVDR Regulations introduce an unique device identification system for medical devices based on a Unique Device Identifier. UDI for medical devices is a string of numeric or alphanumeric characters generated by an internationally recognized device identification and coding standard. UDI compliance is the responsibility of the manufacturer also, to place the unique device identification system on the device label and the package of a device or, in the case of reusable devices, on the device itself (direct marking).
The number will be conveyed through a UDI carrier using Automatic Identification and Data Capture (AIDC) or Human Readable Interpretation (HRI). This carrier should be placed on the label or on the device itself and all higher levels of device packaging.
The unique device identifier system is set to simplify the traceability of medical devices, greatly improve the efficiency of post-market safety activities, and enable more effective monitoring by regulatory bodies. Additionally, it will aid in reducing medical errors and combating counterfeit devices. Ultimately, the implementation of the UDI system is expected to enhance procurement and waste management policies, as well as inventory control by healthcare institutions and other stakeholders.
The new Unique Device Identification system will be implemented for all medical devices, with the exception of custom-made and investigational devices used in performance studies. It is largely grounded in globally recognized principles, particularly through the adoption of definitions that align with those utilized by key trading partners.
Information Source: https://webgate.ec.europa.eu/
Importance of UDI Medical Devices
Unique Device Identification and traceability of the medical devices will enhance the post-market safety-related activities which would lead to:
- Improved incident reporting.
- Regulatory bodies can efficiently monitor the safety and effectiveness of devices on the market, contributing to overall public health.
- Targeted Field Safety Corrective Actions (FSCA);
- Better monitoring by the Competent Authorities.
- Educed medical errors. With a standardized identification system, the chances of errors related to device usage, such as incorrect device implantation or usage of expired products, are significantly reduced.
- Integration of UDI into electronic health records (EHR) and other healthcare IT systems enhances data accuracy and enables better patient care coordination.
- Fight against falsified devices.
- Improved policies on the purchase and disposal of waste and on the management of stocks by health institutions and other economic operators; and
- Compatibility with other authentication systems already in place.
- Patients and healthcare providers can make more informed decisions about medical devices, including understanding the device’s origin, usage, and any associated risks, thereby promoting patient empowerment and engagement.
What is Basic UDI-DI?
The Basic UDI-DI is an EU approach for linking devices to their regulatory documentation and it is intended to uniquely identify the product model throughout the entire life cycle of the product. The Basic UDI-DI is the main key in the database and mentioned in the Technical Documentation and also in the declaration of conformity to connect devices with the same intended purpose, risk class and design characteristics. Basic UDI-DI is different from the packaging/labelling of the device.
The Basic UDI-DI is generated through a globally accepted device identification and coding standard and delivered by accredited UDI issuing entities designated by the European Commission. It is also used as an access key to the information stored in the EUDAMED. Manufacturers should keep in mind any change in EUDAMED data triggers for new Basic UDI-DI. With a change in the Basic UDI-DI, all associated UDI-DIs would also need to be changed
UDI Implementation Deadlines
- MDR Article 123(3)(f), Article 27(4) General Medical Devices
- Implantable and class III devices: 26 May 2021
- Class IIa and class IIb devices: 26 May 2023
- Class I devices: 26 May 2025
- MDR Article 123(3)(g), Article 27(4) reusable devices
- Implantable and class III devices: 26 May 2023
- Class IIa and class IIb devices: 26 May 2025
- Class I devices: 26 May 2027
- IVDR Article 113(3)(e), Article 24(4)
- Class D IVDs: 26 May 2023
- Class C and B IVDs: 26 May 2025
- Class A IVDs: 26 May 2027
UDI System Submission Process
UDI Medical Devices Database
The UDI database will be set up by the European Commission to validate, collate, process, and make available to the public. The technical design of the database will be in such a manner that it will ensure adequate accessibility of information stored, including multi-user access and automatic uploads and downloads of the information. The design will be in a special manner that no UDI-PIs and no commercially confidential product information can be included.
The general principles of UDI database include:
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The UDI database must support the use of all core UDI database data elements;
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For the initial submission and updates of the identifying information and other device data elements in the UDI database, the manufacturer must be responsible;
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Appropriate methods/procedures for validation of the data provided will be implemented;
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Periodical verification of the correctness of all of the data relevant to devices they have placed on the market by the manufacturer, except for devices that are no longer available on the market;
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The presence of the device UDI-DI in the UDI database will not be assumed to mean that the device is in conformity with the MDR;
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The UDI database must allow for the linking of all the packaging levels of the device;
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The data for new UDI-DIs will be available at the time the device is placed on the market;
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Within 30 days of a change being made to an element, which does not require a new UDI-DI, the manufacturers must update the relevant UDI database record;
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Internationally accepted standards for data submission and updates must, wherever possible, be used by the UDI database
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The user interface of the UDI database will be available in all official languages of the Union. The use of free- text fields will, however, be minimized in order to reduce translations
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Data relating to devices that are no longer available on the market will be retained in the UDI database
Appoint I3CGLOBAL as your European Authorized Representative and complete EUDAMED Registration and UDI updation
Frequently Asked Questions
Are Unique Device Identification a public Information?
Yes, It’s a public information. should be submitted to the European Database on Medical Devices (EUDAMED)
What if you have many devices in portfolio? Do I need to have a UDI for each medical device?
Yes! When you have multiple device manufacturer can upload XML files.
What if am a developer of standalone medical software? Does Unique Device Identification applicable?
The UDI number must be assigned to any commercially available standalone software. The software identification shall be regarded as the manufacturing control mechanism and displayed in the UDI-PI. The requirements for software UDI are detailed in Annex VI Part C and the MDCG 2018-5 guidance document.
Who is the major UDI issuing entities?
- GS1 AISBL
- Health Industry Business Communications Council (HIBCC)
- International Council for Commonality in Blood Banking Automation (ICCBBA)
- Informationsstelle für Arzneispezialitäten (IFA) GmbH