The questions
that usually go unanswered.

The base product is registered in EUDAMED (Basic UDI-DI 56006195127RVERTZ) and with INFARMED (Portugal) as a Class I medical device, no. CDM 94571546, and bears the CE mark under MDR 2017/745. 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 EUDAMED registration, Basic UDI-DI 56006195127RVERTZ, and 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 Unpublished work does not count as evidence, and we do not present it as such.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, by another research group, 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.

Often, yes, with prior assessment and supervision. 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. As with any severe cognitive impairment, caution is advised: the team decides case by case whether the person tolerates the headset, and 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 (hi@rver.pt) and to INFARMED, I.P.

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

The Meta Quest 3, with 512 GB. The RVer library is already close to 300 GB (October 2026), and almost every other headset on sale tops out at 256 GB. After that come price, not needing a cable, image sharpness (a blurry image raises the risk of motion sickness), weight, and being wearable over prescription glasses. The headsets belong to RVer: the institution neither chooses nor buys them. The full comparison, spec against spec, is at rver.pt/en/equipamento.

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 was chosen after comparing the models on sale, 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.

The headset, the scene library, the app on the headset, the Companion app (the remote-control dashboard), RVer AI and the service: preparation, training, updates and support. The full list, piece by piece and with the numbers, is at rver.pt/en/especificacoes/.

Because image and battery matter in a clinical session. The cheaper headsets used in healthcare, such as the Pico G3, only follow head rotation (3DoF), use Fresnel lenses, have lower resolution per eye and top out at 128 GB, which cannot hold a library of real scenes in 8K. Their rated battery is around 2 h 30; the Quest 3 gave 2 h 40 playing video in RVer's tests.

Real: filmed by RVer in real places, in 8K or more, at 60 Mbps or more, with ambisonic sound. Every scene is reviewed by independent healthcare teams, and anything that does not work for the people who watch it is removed or reshot.

Not to use it. The scenes are on the headset itself. Connecting to Wi-Fi is optional: with it you get the Companion app, the video call with family and updates.

Yes, by video call: the person sees and hears their family without taking the headset off, and the family sees the person and what they are seeing. The family joins from a link, with nothing to install, using a code valid for one hour.

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.

It depends on the number of sites, extra headsets, modules and how you pay, so we do not publish a price list. Request a quote at rver.pt/en/orcamento/ and you will receive a written proposal by email, with the yearly price and what is included.

Per headset. One licence per site, headset included, with extra headsets on top. You do not pay per video, per session or per user, and each headset can be used 24 hours a day.

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

Yes, at installation, by video call or in person, depending on the case. Every headset also has a getting-started guide that can be replayed whenever needed, for example when someone new joins the team.

As a rule, about 2 weeks, in Portugal and the rest of Europe. Outside Europe, the lead time is agreed case by case.

By email (hi@rver.pt) and WhatsApp, with the team that makes RVer. As a rule, resolved within 3 working days.

For as long as the contract runs, we guarantee everything works, hardware and software. For a hardware fault, RVer replaces the headset as soon as stock allows. Damage caused by misuse is paid for by the institution, and the headset is replaced on payment.

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.