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 (EUDAMED and 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.
ComponentStatusWhat that means
Base product · 360° video libraryRegisteredClass I medical device registered in EUDAMED (Basic UDI-DI 56006195127RVERTZ) and with INFARMED, I.P. (Portugal), no. CDM 94571546, under MDR 2017/745, with the manufacturer established in the European Union (SRN PT-MF-000059840).
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. The EU Declaration of Conformity and the device label are provided on request.
Status as of 17/10/2026 · View the record in EUDAMED ↗
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 in EUDAMED and with INFARMED (Portugal)
For use in healthcare settings
Usable in public (SNS) 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 (SRN PT-MF-000059840). The base product bears the CE mark under MDR 2017/745.
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 (EUDAMED and 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 (hi@rver.pt) and to INFARMED, I.P.
06Documents your board will ask for
The public ones open now. Templates come as PDF, to read, and Word, to fill in. We send the other documents on request, to hi@rver.pt.
- EUDAMED registrationEuropean database on medical devices. Basic UDI-DI 56006195127RVERTZ.RegisteredView in EUDAMED ↗
- EU Declaration of ConformityCE marking under MDR 2017/745.On requestRequest →
- Device labelManufacturer, symbols and CE marking.On requestRequest →
- DPIA template (data protection)Data protection impact assessment pre-filled with what RVer does, for the institution’s DPO to complete. In Portuguese.PublicPDFWord
- Tender specification templateClauses and functional, brand-neutral specifications for Portuguese public procurement. In Portuguese.PublicPDFWord
- Instructions for useIntended purpose, contraindications and use.PublicOpen →
- Equipment specificationsMeta Quest 3, 512 GB, and why it was chosen.PublicOpen →
- Hygiene checklistBefore, between users and at the end of the day.PublicOpen →
- Implementation guidesOne per setting: hospital, care home, palliative care, spa.PublicOpen →
- Privacy and data protectionWho processes data and what is kept.PublicOpen →
- Study libraryPublished research on virtual reality in healthcare.PublicOpen →
07Regulatory questions
For technical documentation, risk assessment or compliance questions.