The Medical Device Coordination Group (MDCG) released a new guidance document on European Unique Device Identifier (UDI) requirements. A UDI system is mandatory under the MDR/IVDR and voluntary under the old Directives.

2022-7 – Q&A on the UDI system under the MDR/IVDR

Below are sample questions from the guidance document, and summarized answers. Please review the full guidance document for all questions and complete answers.

Product & Packaging Changes

Do I need to generate a new UDI-DI if the number of items in a device package is changed (e.g., 5 units per pack to 10 units)?

Generally, yes. A new UDI-DI is required when the following are changed:

• • name or trade name
  • device version or model
  • labelled as single use
  • packaged sterile
  • need for sterilization before use
  • quantity of devices provided in a package
  • critical warnings or contra-indications (e.g. Containing latex or DEHP), CMR/Endocrine disruptors

Do the following described changes to substance-based medical devices require the assignment of a new UDI-DI?

• Formula quantity changes (e.g., from 100 to 120ml) but nothing else changes
• Additional claim but the product remains the same otherwise and looks exactly the same

Yes, a new UDI-DI is required when there is a change in formulation or an extension of claims. Further, the MDCG guidance reiterates that “any changes that may lead to the misidentification of the device or ambiguity in its traceability require the assignment of a new UDI-DI…”

Where a manufacturer assesses that a new UDI-DI is not necessary for a certain type of device change, they should document the rationale for not assigning a new UDI-DI, and why the change will not lead to potential misidentification of the device or any ambiguity in its traceability.

Device Specific: Reprocessed, System/Procedure Packs, Kits

Are the UDI-DIs of a single-use reprocessed devices the same as the original devices?

No. The person responsible for reprocessing the single-use medical device should assign a new Basic UDI-DI and UDI. The person responsible for reprocessing the device should additionally record the UDI for the original product in their technical documentation and quality management system, to ensure traceability.

The exception is if the single use device is reprocessed in a health institution, in which case a new UDI is not required. However, other obligations apply, outlined further in MDR Art. 17(3).

Should a system or procedure pack be assigned its own UDI? Or can the UDI assigned to the devices in the system or procedure pack be used?

Yes, a System or Procedure Pack should have its own UDI assignment, separate from the individual devices in the System or Procedure Pack.

Where should the UDI carrier be placed on systems and procedure packs?

As a general rule, the UDI carrier for a system or procedure pack shall be affixed to the outside of the packaging.

Where the devices in a system are not packaged together, before placing the system on the market, the natural or legal person responsible should assign (identify) the system with a UDI, and ensure that the UDI carrier is affixed so that users may have access to it, including when the system is installed/is used or operating.

Further, each device within the system or procedure pack should, as a general rule, bear their own UDI carrier.

What is a kit and what are the UDI requirements applicable?

Kits are related to IVDs, while Systems & Procedure Packs generally relate to medical devices. Kits are defined as a “set of components that are packaged together and intended to be used to perform a specific in vitro diagnostic examination, or a part thereof”.

Kits shall be assigned and bear their own UDI. As should any components of the kit that are medical devices in their own right and commercially available on their own.

Promotional packs and Marketing related samples

Should devices being used for marketing purposes be assigned and bear a UDI?

‘Devices for special purposes’ set out in Article 21 (3) MDR or Article 19 (3) IVDR, and presented at trade fairs, exhibitions, demonstrations, or similar events, are not required to comply with UDI requirements.

Note that a visible sign clearly indicating that the device is intended for presentation or demonstration purposes only is required, and that the device cannot be made available until it has been brought into compliance with the Regulation.

Traceability

Are distributors and importers required to maintain UDI registry of all the devices which they have supplied, or with which they have been supplied?

Other than a small subset of devices (e.g., MDR Class III implantable devices), the answer is ‘no’.

While importers and distributors should have a system in place for proper traceability, it is not required that they maintain a historical record of all UDIs. However, they may certainly voluntarily choose to do so, to better ensure traceability.

Basic UDI-DI

How should the Basic UDI-DI be assigned? How should the ‘grouping’ for design or manufacturing characteristics be determined?

The manufacturer is ultimately responsible for making this decision, as they have the technical knowledge to understand if products can be grouped under a parent Basic UDI-DI. Devices bundled under a Basic UDI-DI should share the same intended purpose, risk class and essential design and manufacturing characteristics.

Where the same device model is sold under the brand name of the manufacturer and also by a distributor under its name, registered trade name or registered trademark, can the Basic UDI-DI assigned to the manufacturer’s device also be used by the distributor?

No. Importers or distributors that market a medical device available under its own name or registered trademark assume responsibilities related to UDI, among other responsibilities outlined in Art. 16(1) of the MDR/IVDR. Therefore, they must implement their own UDI system, including their own unique Basic UDI-DI assignment.

Should Declarations of Conformity (DoC) reference Basic UDI-DIs, including the check digit?

Yes, it should. The check digit is an integral part of the Basic UDI-DI and should be fully identified in the DoC and in EUDAMED. The Basic UDI-DI is incomplete without the check digit.

Can a Declaration of Conformity (DoC) reference more than one Basic UDI-DI? Can one Basic UDI-DI be referenced in more than one DoC?

Yes, a DoC may reference more than one Basic UDI-DI. As well, the same Basic UDI-DI can be referenced in more than one DoC

UDI Labeling

Are the EU and US UDI requirements the same with respect to UDI labelling? Where a product is sold in the US and is compliant with the FDA UDI labelling requirements, can the same UDI product labelling be used when a placing a product on the market in the EU?

For the most part, yes. This is because the EU and US UDI systems were established through collaborative work at the International Medical Device Regulators Forum (IMDRF) level.

However, there are some differences and manufacturers are responsible for ensuring any gaps between the two systems are addressed. For example, Europe requires a Basic UDI-DI assignment, while the US does not. Further, Europe only recognizes the following four UDI issuing agencies: GS1, HIBCC, ICCBBA and IFA GmbH.

Where does the UDI carrier need to be placed on the label?

The UDI Carrier is required on the label, or on the device itself, and on all higher levels of device packaging. Higher levels of packaging shall not be understood to include shipping containers.

However, some exceptions may be applicable from having to place the UDI carrier on the device or device label:

• • The UDI carrier may be placed on the next higher packaging level if there are significant space constraints.
  • Class I and IIa single-use devices that are packaged and labelled individually are not required to have the UDI carrier on the packaging; instead, it can be placed on a higher level of packaging.

Note that the above are only allowable if the healthcare provider is expected to have access to the higher level of device packaging. If they are not, such as in a home healthcare setting, then the UDI shall be placed on the packaging of the individual device.

What is a UDI carrier?

A UDI carrier is simply the way in which the UDI information is shown on the device labeling.

In Europe, both the ‘automatic identification and data capture’ (AIDC) and human-readable format are required to be included.

Below is an example of a UDI carrier, provided by the FDA in its Guidance document “Unique Device Identification System: Form and Content of the UDI”.