The questions
that usually go unanswered.

The base product is registered with Infarmed as a Class I medical device, no. CDM 94571546, and bears the CE mark under MDR 2017/745. For a Class I device that is non-sterile and has no measuring function, conformity is declared by the manufacturer, with no notified body involved. The EU Declaration of Conformity and the device label are provided on request.

Yes, and it is the institution's decision. Two things are worth separating. The registration: the Class I device is the base product. The video library; RVer Motion, RVer Neuro and RVer Exposure are complements in development and fall outside that scope. Access: the modules are not gated by any Infarmed licence, because that is not how the registration works. They are either included in the contracted package or not, and they are enabled per device. The contract decides whether you see a module; the registration decides what it covers.

No, and it did not have to be. For a Class I device that is non-sterile, has no measuring function and is not a reusable surgical instrument, the manufacturer compiles the technical file, signs the EU Declaration of Conformity, affixes the CE mark and registers the device. That is why the CE symbol appears without the four-digit notified body number: for Class I that is exactly as it should be. The verifiable proof we point to is the Infarmed registration, CDM 94571546.

Not decided yet. What is decided is the opposite: no module is presented as covered until it is.

Most of the library is independent research on virtual reality in healthcare settings, not on RVer. Some texts are written by our own team and are marked as RVer Study. Unpublished work does not count as evidence, and we do not present it as such.

Nothing guarantees it, and we do not claim it does. The published research concerns virtual reality as a technology; it is not a performance claim for RVer. What we do with it is choose content: the library is large because the scenario that suits one person does not suit another, and the team makes that choice.

One that we know of, in five years. Someone who objected from the start because they did not believe in the system. They tried it, spent two or three minutes with the headset, took it off and never wanted to use it again.

Because they exist, and hiding them would be picking the evidence that suits us. There are settings where virtual reality, applied as in those studies, shows no benefit. One study in the library is a trial with 192 military personnel showing equivalence, not superiority, against the conventional method: it is there for that reason.

The manual advises caution or prior clinical assessment in: severe motion sickness or vestibular disorders; uncontrolled epilepsy or photosensitive seizures; inability to follow safety instructions.

Yes. There are institutions dedicated to advanced dementia using RVer every day. It is two steps, and there is nowhere else to press: the interface offers no way to get it wrong. The session is always accompanied by a professional.

No serious incident has been reported to date. Any serious incident with the device must be reported to the manufacturer ([email protected]) and to Infarmed, I.P.

One, in five years, among the cases we know about.

We have had clients try exactly that. The difference sits in three places. The content is prepared to avoid known problems of virtual reality, motion sickness first: framing, camera movement and pacing are chosen with that in mind. The hardware is the best on the consumer market, which is what allows the video to be shown at the highest possible quality. And there is a difference that is not technical: RVer is a registered medical device, with technical documentation and a risk assessment.

No. The AI suggests and explains why it suggested something. The clinical team decides. RVer does not prescribe, assess or diagnose.

The data belongs to the client. No personal or clinical patient data leaves the headset: to that we have no access at all. What the headset sends is per-device usage statistics, which identify no one, and serve to improve the app. We do not sell data.

Yes. There is a private area inside the app, for the team rather than patients. A coffee cup below the module rail, held for three seconds, opens seven games made for virtual reality and a shelf of calm videos the team picks themselves from the device library. Nothing is recorded: no session, no history, no report, no name. There is nothing a manager or an institution can look up, because nothing is kept. While it is running, Companion cannot control the headset or see its screen. With a patient assigned to the device, the cup disappears. A headset in a session does not show the door. It is not a module, it is not sold separately, and it is included with every RVer. It came from clients whose teams were already using the headsets between sessions.

The system runs offline. If the update servers disappeared tomorrow, every headset would carry on playing the library installed on it: for as long as there is electricity to charge it. What would be lost is updates and support, not use.

About five minutes to pick a scenario and fit the headset on the patient. With practice, less.

We have not yet had a client where nobody used it.

We cannot forecast server and licence costs three years out. The expectation is that the subscription stays the same or rises little. We do not promise a figure we do not control.