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List of Notified Bodies (MDR)

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List of Notified Bodies (IVDR)

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UDI System For Medical Devices

UDI Medical Devices

UDI medical devices is a string of numeric or alphanumeric characters generated by an internationally recognized device identification and coding standard. UDI is a European regulation applicable for medical devices and Invitro device identification. It is the responsibility of the manufacturer for placing the unique device identification system on the device label and on the package of a device or, in the case of reusable devices, on the device itself (direct marking).

 

The manufacturer is responsible for complying with all UDI-related requirements including the assignment of the basic UDI-DI and updating EUDAMED database.

 

UDI Medical Devices Labelling Requirements: The UDI medical devices 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.

UDI Medical Devices Benefits

Unique Device Identification and traceability of the medical devices by means of UDI medical devices 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 production of a UDI comprises the following:

UDI System for medical devices enables unambiguous identification of a particular medical gadget on the market. The UDI is made up of the UDI-DI and the UDI-PI. The unique identifier may include lot or serial number information and can be used anywhere in the world.

  • A device identifier UDI-DI of the device provide information covered in Part B of Annex VI.
  • A production identifier UDI-PI of device provide information about packaged covered in Part C of Annex VI.

Basic UDI-DI System

The Basic Unique Device Identifier is the primary access key to device-related information in the EUDAMED database, and it is linked to CE certifications, FSC, DOC, Technical Documentation, and, lastly, GSPR and a summary of safety and (clinical) performance.

 

Its objective is to discover and connect devices that have the same intended purpose, risk class, and critical design and manufacturing features. Any Basic UDI-DI must uniquely identify the devices group covered by the Basic UDI-DI.

  • 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.

UDI Implementation Deadlines

US FDA Approval
  • 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

Major UDI System For Medical Devices issuing entities

US FDA Approval
  1. GS1 AISBL
  2. Health Industry Business Communications Council (HIBCC)
  3. International Council for Commonality in Blood Banking Automation (ICCBBA)
  4. Informationsstelle für Arzneispezialitäten (IFA) GmbH

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:

  • 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

UDI Medical Devices and Software's

US FDA Approval

The UDI 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.

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.