When does a labelling change for your medical device trigger a new UDI-DI?

The myth: a new UDI-DI is only required when the device itself is redesigned

It is commonly assumed that a new UDI-DI follows only from a redesign of the device itself. Under the MDR, this assumption does not hold. Annex VI, Part C, Section 3.9 establishes a distinct test: a new UDI-DI is required whenever a change could lead to misidentification of the device or ambiguity in its traceability. The Commission's own guidance, MDCG 2018-1 Rev.4, sets out what this means in practice, and several of the changes it identifies are labelling changes rather than design changes.

The reality: these changes trigger a new UDI-DI, independent of the device itself

A new UDI-DI is required where any of the following changes:

• the device's trade name or model

• whether the device is labelled as single use

• whether the device is packaged sterile

• whether the device needs sterilisation before use

• the quantity of devices provided in a package

• the maximum number of permitted reuses, where the manufacturer has established one

That last point applies only where a manufacturer has determined, based on clinical evidence and risk management, a maximum number of times a reusable device may be used, something the MDR does not generally require. Where it has been established, for devices such as minimally-invasive robotic instruments, laryngeal masks, or reusable surgical instruments, that number must also appear in the instructions for use, and any change to it requires a new UDI-DI.

MDCG 2018-1 Rev.4 also flags a further change worth specific attention: colour or language on the label. A change of either may also require a new UDI-DI, but only where that change could lead to the product being misidentified or could affect its safety or performance. The guidance gives two worked examples: a change in the colour coding of connectors, latex-free surgical gloves or blood tubes; and two otherwise identical self-testing devices that cannot be substituted for one another because of local labelling requirements, which must carry different UDI-DIs.

In each of these cases, the requirement arises even where the device inside the packaging remains identical to the one previously placed on the market.

When a new UDI-DI is not required

A new UDI-DI is not required for changes to the following, provided the remainder of the label is unchanged:

• lot number

• serial number

• date of manufacture

• expiry date

These fall under the UDI-PI rather than the UDI-DI. The UDI-DI identifies the device model; the UDI-PI identifies the specific unit or production run. Even where a new UDI-DI is not triggered, the existing UDI database record must still be updated within 30 days of the change.

A distinct rule for software

Software-driven devices are governed by a separate provision, Annex VI, Part C, Section 6.5.2, and by the Commission's dedicated guidance on the subject, MDCG 2018-5. A new UDI-DI is required for software wherever a modification changes its original performance, its safety, or its interpretation of data, changes the guidance considers significant enough to include new or modified algorithms, database structures, operating platforms, architecture, user interfaces, or interoperability channels.

Several of the general labelling triggers apply to software too: a change to its name or trade name, its version or model number, a critical warning or contra-indication, or the language of its user interface all require a new UDI-DI as well. A minor software revision, such as a bug fix, a non-safety usability improvement, a security patch, or an efficiency improvement, requires only an update to the UDI-PI, not a new UDI-DI.

Special case address: When a manufacturer solely changes its manufacturing site address, this does not necessarily require a new UDI-DI, although it remains a significant change from a quality management perspective. The position is different where products are transferred to another legal manufacturer, for example through an acquisition. In that case, a new UDI-DI is required, because the Single Registration Number (SRN) of the new legal manufacturer differs from that of the previous one.

Why the distinction matters

Each UDI-DI is associated with one, and only one, Basic UDI-DI, the key identifier used throughout EUDAMED and the device's technical documentation. Correctly identifying when a new UDI-DI is triggered, and when it is not, is what preserves that link, and with it, the traceability the UDI system is designed to guarantee.