This week something new: Data governance

This week something new: Data governance.
Much like the traditional wedding adage of „something old, something new, something borrowed, something blue,“ the merging of the AI Act with the MDR holds similar symbolism.
AI Act and MDR merge: this week something old, promoting inovation or burocracy

The AI Act is published at the official journal of the EU. From that moment, the clock starts ticking for all AI-based software manufacturers. But what about medical devices that utilize AI-based software?
EUDAMED and UDI

18.10.2023 EUDAMED and UDI EUDAMED is the IT system established by Regulation (EU) 2017/74) on medical devices and Regulation (EU) 2017/746 on in vitro diagnosis medical devices and developed by the European Commission. A device identification system based on a unique device identifier (UDI) allows easier traceability of medical devices. Really, EUDAMED and UDI are in essence quite straightforward concepts. But the grouping of devices into Basic UDI-DI device families is essential to make your registrations work, and also for organizing the technical documentation of your full portfolio. Companies that seek confirmation regarding their grouping, can reach out for a short check. This can best be setup by a limited ad hoc budget. If you want to see how to group devices into device families, or need support with the EUDAMED registration feel free to reach out. contact us Back to expert center
The strategic importance of the Basic UDI-DI

18.10.2023 The strategic importance of the Basic UDI-DI The strategic consequences of specific Basic UDI-DI groupings 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 we 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 Strategic considerations 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,
Notified body search and selection

18.10.2023 Notified body search and selection Regulation (EU) 2023/607, ammending the MDR, allows more time for the notified bodies to certify their companies. However, manufacturer must have entered an application with a notified body by 26 May 2024 in order to keep the legacy status of their devices. For companies that are still looking for a notified body, it is the highest time to find the right notified body. Preparation Companies should ensure they are sufficiently ready to face the first level of scrutiny by a notified body by the time they reach out. Perfection is not yet necessary, but one should be close. For first-time companies this can be intimidating and they may appreciate guidance and confirmation from an expert. Profiling AR2-C2 can help companies profile themselves, taking into account their future plans, and match that profile with the profiles of notified bodies. There are some well known notified bodies, but there may be others that could be a better match for the company. Making a successful match involves more than checking notified body designation codes. Connecting In a next step the company must reach out to notified bodies. Although they all have their standard procedure for inquiries, there is still some bandwidth to make a difference during the first impression. Then there are follow up calls, further exchange of information. All that communication must be done with the bigger picture in mind, resulting in a consistent and clear message to the notified body. Here too, support from an expert helps. Get help If you want expert support connecting with a notified body, reach out for a first call in which we can assess where you stand and what could be a good regulatory strategy. contact us Back to expert center