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UDI carrier

1.

Who is responsible for placing the UDI carrier on the device itself, on the label and/or on the package of a device?

The manufacturer is responsible for complying with all UDI related requirements. This includes the assignment of the device's UDI (and Basic UDI-DI), its UDI (and Basic UDI-DI) registration in the EUDAMED database and the placement of the UDI carrier on the label of the device or on its packaging or, in case of reusable devices, on the device itself (direct marking).

2.

For cases of small-sized or oddly-shaped devices (e.g. circular body), does the EU allow for exemptions for placing UDI in Human Readable Information format (HRI) on the device itself, on the basis that UDI direct marking is not technologically feasible?

No.

3.

What are the rules and exceptions for UDI carrier direct marking on medical devices?

According to Annex VI, Part C, Section 4.10, the rules and exemption for the UDI carrier are defined as follows:

"Devices that are reusable shall bear a UDI carrier on the device itself. The UDI carrier for reusable devices that require cleaning, disinfection, sterilisation or refurbishing between patient uses shall be permanent and readable after each process performed to make the device ready for the subsequent use throughout the intended lifetime of the device."

The requirement of this Section shall not apply to devices in the following circumstances:

  • Any type of direct marking would interfere with the safety or performance of the device

  • The device cannot be directly marked because it is not technologically feasible.

The UDI carrier is the means of conveying the UDI by using AIDC and, if applicable, the HRI. The UDI carrier (AIDC and HRI representation of the UDI) shall be placed on the label or on the device itself and on all higher levels of device packaging.

It is noted that single use devices are not covered by this requirement.

4.

Will Articles 31(2) and 27(3) from the MDR be applicable on DOA (e.g. 05/26/2020) for medical devices currently compliant with the MDD 93/42/EEC?

Art. 27(3) – Regarding UDI assignment, for MDR compliant devices this will apply as from 05/26/2021. For devices considered legacy devices, please refer to the published Guidance MDCG 2019-5.

Art. 31(2) – please note that a solution on the SRN is under development, and that in the absence of EUDAMED, it cannot be centrally administered.

5.

Can we have a different issuing entity between a direct marking UDI-DI and a UDI-DI for the same device?

It is not possible to have a different issuing entity between a direct marking UDI-DI and a UDI-DI for the same device.

6.

If a medical device is in a pack with only non-medical devices (e.g. medicine, plastics, reagents etc.), does the UDI need to be assigned to the pack or to the medical device only?

If the procedure pack is covered by Article 22 of the MDR, the procedure pack must be identified with a UDI (UDI-DI + UDI-PI). The medical device contained in the procedure pack must also be identified with the UDI information, if no exemptions are applicable as defined in Annex VI, Part C, Section 6.3.2 of the MDR.

7.

How to assign a UDI to procedure pack / configurable device components if they are medical devices in their own right or are implantable devices?

Requirements for systems / procedure packs:

According to Annex VI, Part C, Section 6.3.2 of the MDR:

Device contents of systems or procedure packs shall bear a UDI carrier on their packaging or on the device itself.

Exemptions:

  • Individual single-use disposable devices, the uses of which are generally known to the persons by whom they are intended to be used, which are contained within a system or procedure pack, and which are not intended for individual use outside the context of the system or procedure pack, shall not be required to bear their own UDI carrier.

  • Devices that are exempted from bearing a UDI carrier on the relevant level of packaging shall not be required to bear a UDI carrier when included within a system or procedure pack.

Requirements for configurable devices:

According to Annex VI, Part C, Section 6.4 of the MDR:

A UDI shall be assigned to the configurable device in its entirety and shall be called the configurable device UDI.

Each component that is considered a device and is commercially available on its own shall be assigned a separate UDI.

Specific requirements for implantable devices, according to Annex VI, Part C, Section 6.1:

Implantable devices shall, at their lowest level of packaging (unit packs), be identified or marked with a UDI (UDI-DI + UDI-PI) using AIDC (automatic identification and data capture);

The UDI-PI shall have at least the following characteristics:

  • The serial number for active implantable devices

  • The serial number or lot number for other implantable devices.

The UDI of the implantable device shall be identifiable prior to implantation.

8.

If a device is sold exclusively at retail point of sale, are the UDI PI information to be provided in the AIDC format?

The UDI-PI information is not required to appear on the label in AIDC format on the point of sales packaging if the device is exclusively sold at retail point of sale. The MDR 2017/745 excludes the UDI PI information from AIDC format on the point of sales packaging level, however, the exception is not applicable for the HRI, which needs to be identified on the point of sales packaging. The mentioned exception is defined for the sales packaging level only, so the primary packaging level must be in compliance with UDI requirements as defined in MDR (UDI-DI and UDI-PI in both AIDC and HRI format).

For devices exclusively intended for retail point of sale the UDI-PIs in AIDC shall not be required to appear on the point-of-sale packaging.