Identification and Traceability

One of the major innovations introduced by the new MDR and IVDR regulations is an advanced system for the identification and traceability of devices, as well as the registration of devices and economic operators. The foundation of this system is set forth in Article 25 of Regulation (EU) 2017/745, which establishes standards for identification within the supply chain. In accordance with this standard, distributors and importers must collaborate with manufacturers or their designated agents to ensure an appropriate level of device traceability.

Economic operators are required to be able to identify:

  • Each economic operator to whom they have directly supplied a device;
  • Any economic operator from whom they have directly received a device;
  • Any healthcare institution or provider to which they have directly supplied a device.

To meet these requirements, Regulations (EU) 2017/745 and 2017/746 mandate the implementation of the Identification and Traceability system through the use of the Unique Device Identification (UDI) system.

The system requires the assignment of a basic UDI-DI for each homogeneous group of devices. This approach extends control across the entire manufacturing and distribution chain—including importers and distributors—while providing a reference point for the surveillance and vigilance system. It supports critical processes such as:

  • Identification and reporting of adverse events
  • Implementation of recall actions
  • Management of post-market activities
  • Ongoing post-market monitoring and surveillance

It is important to note that the UDI system does not apply to custom-made medical devices or those currently under study or investigation.

Key elements of the system include:

  • Assignment of a Basic UDI-DI: Each group of devices is assigned a unique UDI-DI, which will be registered in Eudamed.
  • Generation of a Complete UDI: A complete UDI is produced, comprising the UDI-DI (device identifier) and the UDI-PI (production identifier).
  • UDI Labeling: The UDI vector is affixed to the device label.
  • UDI Data Management: All UDI information is recorded and stored to ensure comprehensive traceability.
Key Compliance Deadlines::
  • Medical Devices (MDR) – UDI on Device Labels:
    1. Implantable and Class III devices: May 26, 2021
    2. Class IIa and IIb devices: May 26, 2023
    3. Class I devices: May 26, 2025
  • Marking of Reusable Devices:
    1. Implantable and Class III devices: May 26, 2023
    2. Class IIa and IIb devices: May 26, 2025
    3. Class I devices: May 26, 2027
  • In Vitro Diagnostic Devices (IVDR) – UDI on Device Labels:
    1. Class D IVD: May 26, 2023
    2. Class C and B IVD: May 26, 2025
    3. Class A IVD: May 26, 2027

The UDI vector can be affixed using either a barcode or a datamatrix, while ensuring that the label also includes a Human Readable Interpretation for manual verification. The UDI issuing bodies establish the specifications necessary to guarantee unambiguous traceability.

Eumed, leveraging its well-established collaborative relationships with these issuing bodies, is well-equipped to provide the necessary assistance for the proper implementation of the device identification and traceability system. This includes facilitating registration in the Eudamed database—complete with our own access credentials—and acting as a subcontractor for the manufacturer.

Furthermore, in light of the latest advancements in Eudamed’s computerized systems, our company can now communicate with the system through established IT protocols, significantly expediting the communication and registration process.