MDCG 2022-7: UDI Q&A, explained

Who this applies to

MDCG 2022-7 supplements the MDR and IVDR UDI rules with answers for common product and supply-chain situations. It is most useful after the manufacturer has defined a UDI process and needs to resolve a specific grouping, labelling or responsibility question.

The answers do not replace the general rule: the legal manufacturer is responsible for compliant assignment, registration and labelling unless another operator has assumed the manufacturer's obligations under a specific regulatory provision.

Identifier changes and product variants

A new UDI-DI is required when a change could cause misidentification or ambiguity in traceability. A change in the number of items in a device package is one example: the package needs a new UDI-DI because its quantity has changed.

Changes to name, model, sterile or single-use status, critical warnings and other identification attributes also need assessment. Similar products, private-label arrangements and reprocessed devices cannot simply inherit an identifier without first establishing who is the legal manufacturer and which obligations that party has assumed.

Basic UDI-DI grouping

The Basic UDI-DI is the main database and documentation key for devices with the same intended purpose, risk class and essential design and manufacturing characteristics. Grouping should be designed early enough to remain workable in certificates, declarations, technical documentation and post-market reports.

The declaration of conformity should carry the complete Basic UDI-DI, including its check digit. A declaration may reference more than one Basic UDI-DI, and one Basic UDI-DI may appear in more than one declaration when the regulatory scope supports that structure.

Branding arrangements need special care. If an operator markets a device under its own name and thereby becomes the manufacturer, it must meet the UDI obligations and assign its own Basic UDI-DI and UDI. If the original manufacturer remains identified as manufacturer on the label under the applicable arrangement, the original Basic UDI-DI may remain relevant.

Carrier and packaging rules

The UDI carrier combines automatic identification and data capture with a human-readable interpretation. It is placed on the label or device and on higher packaging levels as required. Shipping containers are not treated as higher packaging levels for this purpose.

Before approving a label, confirm:

• the correct UDI-DI for that device and packaging level;
• the applicable production identifiers;
• carrier position, readability and issuing-entity syntax;
• any exception for individually packaged and labelled class I or IIa devices; and
• whether a reusable device also requires direct marking.

EU and US UDI frameworks are not identical. The same physical label may work only when it independently satisfies both jurisdictions and the identifiers come from an issuing entity recognised for the relevant system.

Special configurations need their own analysis

The guidance includes answers for systems and procedure packs, configurable devices, kits, single-use device reprocessing and other combinations. Do not assume that the identifier of one component identifies the assembled product. Determine whether the configuration is a device in its own right, who assumes manufacturer obligations and which level needs a Basic UDI-DI, UDI-DI and carrier.

For IVD kits, assign identifiers to the kit itself when it is a device in its own right. Components may retain their own identifiers where applicable.

What this means for you, practically

Maintain a controlled table connecting each marketed configuration to its legal manufacturer, Basic UDI-DI, unit-of-use and package UDI-DIs, UDI-PIs, label artwork, direct-marking decision and EUDAMED record. Review it at each change and release.

Use MDCG 2018-1 for the grouping and identifier-change foundation, MDCG 2018-5 for software, and MDCG 2021-19 to control the process in the QMS.

Read the official MDCG 2022-7 guidance.