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Unique Device Identification System

The EU MDR 2017/745 has brought about many changes and one among them is the introduction of Unique Device Identification System or the UDI System for the identification and traceability of medical devices. It is mentioned in Article 27 and part C of Annex VI.
Unique Device Identification System

Need of Unique Device Identification System (UDI system)?

Identification and traceability of the medical devices by means of UDI system will enhance the post-market safety-related activities which would lead to:

  • Improved incident reporting;
  • Targeted Field Safety Corrective Actions (FSCA);
  • Better monitoring by the Competent Authorities;
  • educed medical errors;
  • 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.

The UDI System

The UDI system is comprised of the following:

a) Production of UDI, which comprises of:

  • UDI-DI: Device Identifier, specific to a manufacturer and a device. It is used for device identification and traceability. It is comprised of unique numeric or alphanumeric code specific to the model 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.

b) UDI labelling on the device or on its packaging

c) UDI storage by the economic operators, health professionals, and the health institutions

d) Establishment of the UDI Database (UDID)

Labeling Requirements

US FDA Approval

The UDI will be conveyed through a UDI carrier using Automatic Identification and Data Capture (AIDC) or Human Readable Interpretation (HRI). This UDI carrier should be placed on the label or on the device itself and on all higher levels of device packaging.

Storage Requirements

US FDA Approval

Member States have encouraged and may require health institutions to store and maintain, preferably by electronic means, the UDI of the devices with which they were supplied, for devices other than Class III implantable devices. If the devices belong to Class III implantable devices, health institutions should preferably store and maintain, by electronic means, the UDI of the devices they have supplied or with which they were supplied. Member States have encouraged and may require healthcare professionals to store and maintain UDI of devices with which they have been supplied, preferably by electronic means. Economic operators should store and maintain the UDI of the devices they supplied or with which they were supplied, preferably by electronic means, where such devices belong to Class III implantable devices and devices, categories, or groups of devices.

UDI 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:

  • The UDI database must support the use of all core UDI database data elements;
  • For the initial submission and updates of the identifying information and other device data elements in the UDI database, the manufacturer must be responsible;
  • Appropriate methods/procedures for validation of the data provided will be implemented;
  • 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;
  • 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;
  • The UDI database must allow for the linking of all the packaging levels of the device;
  • The data for new UDI-DIs will be available at the time the device is placed on the market;
  • 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;
  • Internationally accepted standards for data submission and updates must, wherever possible, be used by the UDI database
  • 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
  • Data relating to devices that are no longer available on the market will be retained in the UDI database