role-of-the-udi-in-the-traceability-of-medical-devices

The UDI code is the unique identifier of the medical device required by the new regulation of the medical device.

 

MEDICAL DEVICE REGULATIONS

The new Regulation (EU) 2017/745 on medical devices (“MDR”) and Regulation (EU) 2017/746 on medical devices for in vitro diagnostic (“IVDR”) English) adapt EU legislation to technical advances, changes in medical science, and legislative developments.

 

For medical devices, the transitional period ended on May 26, 2020, that is, on the 'application date' of the MDR. In the case of in vitro diagnostic medical devices, the transitional period will end on May 26, 2022, that is, on the IVDR "application date".

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TRACEABILITY AND IDENTIFICATION

A new feature introduced by the Regulations is the unique UDI identification system (article 27 of the MDR and article 24 of the IVDR). This system will improve the identification and traceability of products and provide interested parties with access to basic information on products through the European Database on Medical Devices (Eudamed).

 

All in vitro diagnostic and medical devices and, as appropriate, all packaged products, will have a numeric or alphanumeric code " UDI" consisting of two parts:

 

Device Identifier (UDI-DI): It is the static and mandatory part of a UDI, it identifies the manufacturer and the specific version or model of a device.

 

Production Identifier  (UDI-PI): It is the conditional dynamic part of a UDI, it identifies one or more data (batch number, serial number, expiration date, manufacturing date) when it is included on the label of a medical device.

 

By this, the UDI code that we remember is the unique identifier of the medical device or the label that incorporates it, will be considered part of the product information, which must unconditionally accompany it and which must be part of the Technical Documentation of product, as well as the Registry that each Organization determines, about the risk class of the product and the product traceability operation itself.

 

TARGET DATES OF THE UDI ON THE MEDICAL DEVICE

The deadline for the assignment of UDIs is the date of application of the corresponding Regulation (May 26, 2020, in the case of MDR and May 26, 2022, in the case of IVDR); however, the obligation to place the UDI on the label will be fulfilled in three stages:

 

In the case of medical devices, the UDI must be affixed, at the latest, on the following dates:

 

  1. Class III products: May 26, 2021.
  2. Class II products: May 26, 2023.
  3. Class I products: May 26, 2025.

For in vitro diagnostic medical devices:

  1. Class D products: May 26, 2023.
  2. Class B and C products: May 26, 2025.
  3. Class A products: May 26, 2027

 

Manufacturers are responsible for entering the necessary data in the European database ( EUDAMED ), which includes the UDI database, as well as keeping it up to date.