It does not prescribe, assess or diagnose
RVer AI ranks the library and shows the evidence behind each suggestion. The choice is always the team's.
What is registered,
and what is not yet.
The question any service asks before buying. Answered on its own page, not in small print at the end of another one.
01What the registration covers
The Class I medical device registration (Infarmed, MDR 2017/745) covers the base product: the video library. The modules are complements in development and are not covered. The base product bears the CE mark under MDR 2017/745, self-declared by the manufacturer with no notified body.
ComponentStatusWhat that means
Base product · 360° video libraryRegisteredClass I medical device registered with Infarmed, I.P., no. CDM 94571546, under MDR 2017/745, with the manufacturer established in the European Union.
RVer Motion: guided movementNot coveredModule in development. Outside the scope of the registration.
RVer Neuro: cognitive activitiesNot coveredModule in development. Outside the scope of the registration.
RVer Exposure: graded exposureNot coveredModule in development. Outside the scope of the registration.
CE marking: base productAffixedCE marking under MDR 2017/745, self-declared by the manufacturer with no notified body. The EU Declaration of Conformity and the device label are provided on request.
Status as of 23/09/2026
02What RVer does not do
Worth writing out in full, rather than inferring it from what goes unsaid.
It does not replace clinical assessment or judgement
It is a non-pharmacological complement, used under the supervision of the healthcare team.
It is not for self-administration
The intended users are healthcare professionals and trained carers. The patient is always supervised.
It does not collect clinical patient data
No personal or clinical data leaves the headset. Only per-device usage statistics, which identify no one.
03Regulatory framework
Medical Device Class I (base product)Registered with Infarmed, I.P.
For use in healthcare settings
Usable in NHS and private hospitals, clinics and health centres across Portugal, under team supervision.
Technical documentation and risk assessment
Complies with technical documentation, risk assessment and European standards (MDR 2017/745).
Privacy by design
No personal or clinical patient data leaves the headset. Only per-device usage statistics, identifying no one, to improve the app (GDPR).
Registered in Portugal, CE-marked
Medical device registration in Portugal under MDR 2017/745, with the manufacturer established in the European Union. The base product bears the CE mark under MDR 2017/745, self-declared, with no notified body.
04The evidence we rely on
We collect published research on virtual reality in healthcare settings. Most of it comes from independent teams; our own team also publishes, and those texts are marked as such.
Most are by independent, peer-reviewed authors; the texts marked as RVer Study are written by our team. None of them is a performance claim for the product, nor a substitute for clinical assessment. The Class I medical device registration (Infarmed) covers the base product.
05Caution and contraindications
Contraindications
Caution or prior clinical assessment in: severe motion sickness or vestibular disorders; uncontrolled epilepsy or photosensitive seizures; inability to follow safety instructions.
Intended user
Healthcare professionals and trained carers, in health or social-care settings. The user is always supervised. Not for self-administration.
Reporting incidents
Report any serious incident to the manufacturer ([email protected]) and to Infarmed, I.P.
06Regulatory questions
For technical documentation, risk assessment or compliance questions.