Is a new UDI-DI required? Decision tree
Tick changes such as name, model, package quantity, sterility, warnings or software version, and we show the outcome, the reasoning and the relevant provision for each. This is a preliminary assessment and does not replace your regulatory lead.
What is changing in the device? (you can select several)
Select one or more changes; the result appears here.
This is a preliminary assessment; it does not replace legal or regulatory advice. Verify the result with your notified body or regulatory lead. The legislation in force and the current revision of MDCG 2018-1 prevail.
If you would like to review your UDI master data, label templates and change management process together, get in touch.
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How to use it
A
Choose the regulation you fall under: MDR or IVDR.
B
Tick the changes taking place in the device or its packaging; use "Other" if needed.
C
Read the summary and, for each change, the reasoning and the basis; copy the summary into your change file.
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UDI-DI, UDI-PI and Basic UDI-DI: what does each identify?
A UDI-DI identifies a specific device model and packaging level; in the GS1 system it is a GTIN. The UDI-PI carries production-specific information: batch, serial number, manufacturing and expiry date, software identification. The UDI-DI changes with the product and its packaging; the UDI-PI changes with every production run.
A Basic UDI-DI identifies a group of devices with the same intended purpose, the same risk class and the same essential design and manufacturing characteristics; several UDI-DIs can sit under one Basic UDI-DI. If one of these three characteristics changes, a new Basic UDI-DI is required. The Basic UDI-DI does not appear on the label.
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Changes that require a new UDI-DI
MDR Annex VI Part C, 3.9, requires a new UDI-DI for changes that could lead to misidentification of the device and/or ambiguity in its traceability, and expressly lists changes of: name or trade name; device version or model; labelling as single use; packaging as sterile; need for sterilisation before use; quantity of devices in a package; critical warnings or contra-indications (e.g. containing latex or DEHP).
Because each packaging level has its own UDI-DI, one change can affect several levels and each level is assessed separately. Whether a change requires a new Basic UDI-DI depends on the three characteristics above (intended purpose, risk class, essential design and manufacturing).
04
Software and unclear cases
For device software, MDR Annex VI Part C, 6.5, distinguishes major from minor updates: major updates that change the functionality of the software require a new UDI-DI, minor corrections (e.g. a bug fix) a new UDI-PI. Minor revisions are identified by a manufacturer-specific form of identification.
For changes that are not on the 3.9 list, such as colour, language or packaging material, the tool says "further assessment needed"; the approach to these changes is covered in the additional explanations of MDCG 2018-1 (current revision). Read the detail there and verify the result with your notified body or regulatory lead.
FAQ
- Is what I select sent anywhere?
- No. The assessment runs entirely in code inside your browser; your selections are neither transmitted to a server nor stored.
- Is a new UDI-DI required if the quantity in the package changes?
- Yes. MDR Annex VI Part C, 3.9 (f), lists a change in the quantity of devices in a package among the changes that require a new UDI-DI. If a box of 10 becomes a box of 12, that packaging level gets a new UDI-DI.
- Does the UDI-DI change when the batch number or expiry date changes?
- No. Batch, serial number, manufacturing and expiry date belong to the UDI-PI and change with every production run. The UDI-DI stays the same.
- Is a new UDI-DI needed for a colour or language change?
- These changes are not on the 3.9 list; the tool says further assessment is needed. The question is whether they could lead to misidentification or ambiguity in traceability. Consult MDCG 2018-1 and your regulatory lead.
- Does this also apply to the IVDR?
- IVDR (2017/746) Annex VI Part C has corresponding provisions. The tool applies the same logic but does not give clause numbers; verify the list and numbers in the IVDR text.
- Is this tool a conformity assessment or legal opinion?
- No. It is a preliminary assessment and does not replace advice. Verify the result with your notified body or regulatory lead.
Change management and UDI master data: connected?
In our serialization and labelling projects we add a "does this affect the UDI-DI?" step and a master data check to the product change process, so a change is noticed before it reaches the label.