The strategic consequences of specific Basic UDI-DI groupings
As can be read elsewhere, a Basic UDI-DI groups devices with the same intended purpose and the same essential design and manufacturing characteristics into device families. Within this context a company can chose to apply various levels of granularity. This freedom should be used with great caution, because each option has its own consequences. For example, large device families will keep the numbers of sets of technical documentation down, but the individual documents may increase in complexity.
A UDI-DI can only be linked to one Basic UDI-DI. This also means that a change in the Basic UDI-DI triggers a change in the UDI-DI. If a Basic UDI-DI is linked to a UDI in another market, a change there will also trigger a change in the UDI-DI. So it is strongly recommended to have identical device groupings for UDI purposes globally. The MDR has the strictest Basic UDI-DI requirements, in almost all cases other markets can follow that same structure. It is therefore important to pay sufficient attention to defining the Basic UDI-DI device groupings, and preferably start there. Below you can read how the Basic UDI-DI is used and what the consequences can be of certain choices.
This is where the Basic UDI-DI goes
The MDR and IVDR specify that the Basic UDI-DI must appear on:
- The Declaration of Conformity (MDR Article 27(6), IVDR Article 24(6));
- For Class III and Class llb implantable medical devices as well as IVD’s of Class D and Class C companion diagnostics the Basic UDI-Di must listed on the product certificate;
- The Summary of Safety and Clinical Performance, required for Class III and implantable devices, and the Summary of Safety and Performance, required for Class C and Class D IVD’s;
- The Basic UDI-DI is also required for a Certificate of Free Sales;
- On top that, the device description in the technical documentation must be identified by the Basic UDI-DI.
This implies the Basic UDI-DI is used to link a device to specific documents and vice versa. This is how the physical reality of a device in all its interactions with patients and other users is related to the paper reality in the regulatory world.
One to one, one to many, many to one
With the Basic UDI-DI as the key identifier of a grouping of devices in EUDAMED, it is obvious that all related documents should also be identified by that Basic UDI-DI. From a legal perspective, it is possible to have multiple Basic UDI-DI linked to a single technical document. For example, a clinical evaluation report may list more than one Basic UDI-DI. However, from a practical point of view there may be risk of inconsistencies and increased complexity if the risks are weighed against the clinical benefits of devices with different intended purposes and/or essential design or production characteristics. Therefore it is recommended to apply as much as possible a ‘one to one’ strategy: in most cases there is exactly one Basic UDI-DI mentioned in relevant parts of the technical documentation. There are some exceptions, like for example MDCG Guidance 2022-7 on Questions and Answers on the UDI System in question B5 sets out that a Declaration of Conformity (DoC) can reference multiple Basic UDI-DI’s. However, that same question also sets out that ‘the same Basic UDI-DI can be referenced in more than one DoC’. Two DoC’s may be signed on different dates, it is obvious this may be confusing. It might be better to add a product addendum to the DoC with the details of the individual models and add new models, falling under the same Basic UDI-DI, with an extra addendum. That provides clear linking to a single DoC and relevant technical documentation and also provides clear information from when the individual device was CE-marked.
Level of granularity
With the above ‘one to one’ leading principle for documentation in mind, the level of granularity of the Basic UDI-DI is another strategic issue. There is some room for companies to play with. On the one hand, they may go for a high level of granularity with narrowly defined device groupings and also a high number of sets of technical documentation, each addressing a limited selection of devices. On the other hand, they may go for wider defined groupings, with fewer sets of technical documentation that each handle a large number of devices. This is something to carefully consider. For example, a company has grouped all devices into one, very widely defined Basic UDI-DI. They decide to change something in one device that would require a new Basic UDI-DI. That means that either this device must be removed from the grouping and have its own Basic UDI-DI, or all devices will get this new Basic UDI-DI. A new Basic UDI-DI means a change in the UDI on the label and such change will in most cases also have an impact on UDI’s on other markets.
This is why I usually recommend a high level of granularity in the Basic UDI-DI and where possible just copy parts of the technical documentation that can be copied. Narrow, well defined device groupings often allow for flexibility in device changes, so the Basic UDI-DI structure will not be something that is limiting innovation
Still, with the above in mind, there could be good grounds to go for larger device families. To do that, you must apply a holistic approach and assess the full character of the company. Obviously, that is highly individualized for each organization, but there are some key considerations to go either way:
- If a device family is mature and on the market for quite a while, changes in the device will most likely come in small incremental steps and major breakthroughs will result in a new Basic UDI-DI, this is a typical good reason for a large grouping;
- In case a device is controlled by software and the impact of the software in the diagnostic or therapeutic process is significant, it is more likely there will be serious updates in the software that impact intended purpose and/or output parameters. Such devices should more likely be grouped in smaller families.
- If sales numbers for individual devices are low, and the differences in design are small, it could make sense to group these devices in larger groups to gain more PMS data. This should be done with great care of course.
- Some companies sell their devices under multiple brand names, other keep them all under the same brand name. It is easy to see that the UDI-DI structure for the first type of company is less stable and would be helped by going for a higher granularity in Basic UDI-DI, so a Basic UDI-DI trigger may have less impact on the whole UDI-DI structure.
- For procedure packs or systems it is important to have a detailed intended purpose definition of its components. That means that devices that are likely to end up in procedure packs or systems require a high granularity in Basic UDI-DI, because of the high level of detail in the intended purpose.
Setting up the structure for your Basic UDI-DI will define the structure of your technical documentation. Your notified body will ask you to justify your groupings. You may want to have an external expert reflect on your approach before you send to a notified body. For help with that and other EUDAMED and UDI related questions, just reach out.
Next week I will dive deeper into the subject of UDI for systems and procedure packs. To be continued…