Medical Disclaimer

1. Nature of the Service

VRET (hereinafter, “the Software”) is a professional support technology tool designed exclusively for use by licensed psychologists and duly authorized mental health professionals in the context of supervised therapeutic sessions.

The Software provides virtual reality environments that the professional uses as a complementary resource within their clinical practice. The indication, supervision, clinical application and interpretation of the results correspond entirely to the professional in charge.

2. What the Software is NOT

Not classified as a medical device under Regulation (EU) 2017/745 (MDR) provided it is used within the intended purpose described in section 2bis; it is not standalone software for diagnosis, prescription or treatment.
Not a medical or psychological treatment in itself.
Not a substitute for diagnosis, clinical assessment or professional intervention.
Not a self-help device, nor is it designed for direct use by patients without professional supervision.
Does not perform diagnoses, does not propose individualized treatments, does not prescribe or modify clinical parameters autonomously.
Does not include telemedicine or direct remote patient care. The session always takes place with the psychologist present (in person, or remotely with the patient under their supervision).
Does not collect biometric data from the patient (heart rate, HRV, skin conductance, eye-tracking, EEG, etc.). If in the future any scenario were to incorporate biometric metrics, it would require explicit consent under Art. 9.2.a and a re-assessment of the regulatory framing.

2bis. Boundary of Use and MDR Framing

The statement “VRET is not a medical device” holds provided that use of the Software remains within the following boundary:

What CAN be done with VRET today

Accompany relaxation and mindfulness sessions as an ambient resource.
Serve as technical support for graduated exposure therapy (cynophobia, claustrophobia, acrophobia, specific phobias), under the psychologist’s indication and control.
Capture subjective markers (SUDS) and clinical notes that the professional integrates into their own external clinical record.
Record the virtual environment shown to the patient for later clinical review by the professional themselves.

What CANNOT be done with VRET

Use VRET with an explicit prescriptive medical purpose (for example, “standardized curative treatment of PTSD”, “chronic pain treatment as a therapeutic device”) without the corresponding prior regulatory assessment.
Make clinical decisions based exclusively on automated outputs of the Software.
Replace professional contact or use it as an autonomous self-treatment tool by the patient.
Share the catalog or the recordings with third parties other than the authorized care team of the Controller.

If the psychologist or the clinic wishes to use the Software outside this boundary, they must first contact VRET (contacto [arroba] vret.es) to assess whether such use constitutes a change of purpose that triggers classification as a medical device and, where applicable, the need for certification under the MDR.

VRET reserves the right to review this boundary and, where appropriate, to submit to a certification procedure those scenarios or modules whose declared purpose approaches the regulatory concept of a medical device, before their launch.

United States (FDA). The same boundary-conditioned framing applies outside the European Union. With its current intended purpose, the Software is not a medical device under the US Federal Food, Drug, and Cosmetic Act; no FDA clearance or approval has been sought or is required. It is a wellness/support tool used under the supervision of a licensed professional. The boundary of use in this section applies identically.

United Kingdom (MHRA). For the United Kingdom, the same analysis applies under the UK Medical Devices Regulations 2002 and MHRA “Software as a Medical Device” guidance: within its intended purpose the Software is not a medical device. The boundary of use applies identically.

As with the EU MDR framing above, these conclusions are conditional, not categorical: a change in the intended purpose of the Software triggers a fresh regulatory re-assessment in each jurisdiction (European Union, United States and United Kingdom) before any such use.

3. Exclusive Use Under Professional Supervision

The Software must be used solely and exclusively under the direct supervision of a licensed psychologist or a mental health professional legally authorized to practice in their jurisdiction.

The professional is solely responsible for:

The clinical assessment of the patient before each session.
The selection of scenarios appropriate for each clinical case.
The control and supervision of the virtual reality session in real time.
The immediate interruption of the session if the patient shows distress, excessive anxiety or another adverse reaction.
The subsequent evaluation of the results and their integration into the therapeutic plan.
Obtaining the patient’s written informed consent or, where applicable, that of the legal guardian.

4. Contraindications and Precautions

The professional must assess the following contraindications before using the Software with a patient:

Photosensitive epilepsy or a history of seizures.
Severe unstabilized dissociative disorders.
Active psychotic crisis or acute psychotic symptoms.
Severe post-traumatic stress disorder without prior stabilization.
Severe vestibular or balance problems.
Severe motion sickness (cinetosis).
First-trimester pregnancy with prior vertiginous conditions.
Minors without the express consent of the legal guardian and appropriate clinical assessment.
Any other condition that the professional considers incompatible with exposure to virtual reality environments.

The assessment of the patient’s suitability is the exclusive responsibility of the professional.

5. Scientific Evidence and Limits

Virtual reality exposure therapy (VRET, Virtual Reality Exposure Therapy) is supported by scientific evidence published in indexed journals that endorses its usefulness as a complementary tool for the treatment of anxiety disorders and specific phobias, post-traumatic stress disorder and stress-related disorders.

However, results may vary depending on the patient, the pathology, the therapeutic approach, the dose (number and duration of sessions) and other clinical factors. VRET does not guarantee specific therapeutic results in individual cases. Efficacy depends on appropriate professional use within a complete therapeutic framework.

6. Limitation of Liability

VRET, its developers, administrators and collaborators:

Do not assume clinical responsibility for the results of the therapeutic sessions carried out with the Software.
Are not responsible for clinical decisions made by the professional regarding indication, scenario selection, session duration, dosing or treatment suitability.
Are not responsible for adverse reactions that the patient may experience during or after a session, including: anxiety, distress, dizziness, nausea, disorientation, intense emotional reactions or dissociative episodes.
Do not provide medical, psychological or clinical advice of any kind.

Responsibility for the use of the Software rests entirely with the professional who administers it. The quantitative limitation of VRET’s liability towards the contracting professional is governed by the Terms of Service.

7. Hardware

The virtual reality headset and associated hardware are acquired directly by the professional or the clinic. VRET does not manufacture, distribute or warrant the hardware used. The professional is responsible for keeping the hardware in adequate conditions of hygiene and operation, verifying its compatibility with the Software and informing the patient about the use of the device.

8. Patient Informed Consent

VRET strongly requires that the professional obtain the patient’s written informed consent (or that of the legal guardian in the case of minors) before using the Software, including:

An explanation of the nature of the virtual reality session.
Possible side effects (dizziness, anxiety, distress).
The patient’s right to interrupt the session at any time.
Information on the processing of clinical data during the session (see Privacy Policy).
In the case of recording of the virtual environment, specific and explicit consent under Art. 9.2.a GDPR, given that the recording includes the psychologist’s voice and, where applicable, the patient’s voice and behavior.

VRET may provide a guidance template for informed consent as a reference. In any case, the professional is solely responsible for drafting, adapting, collecting and archiving that document in accordance with their clinical practice and applicable regulations. The obligation to collect the patient’s consent rests with the Data Controller (psychologist or clinic), not with VRET.

9. Adverse Event Reporting

Although VRET is not classified as a medical device and is not subject to the MDR’s post-market surveillance obligations, we consider it essential that any significant adverse event associated with the use of the Software (unexpected dissociative reactions, clinical worsening, hardware incidents during a session) be reported to the VRET team. This allows us to update the contraindications, improve the clinical safety of the product and properly document the boundary of use.

Channel: seguridad [arroba] vret.es with the subject “Adverse event”. We handle reports confidentially and, unless instructed by the Controller, without identifying the patient.

10. Contact

For any query about this notice:

General email: contacto [arroba] vret.es
Privacy: privacidad [arroba] vret.es
Safety and adverse events: seguridad [arroba] vret.es
Address: Rayan Chelouati (self-employed professional), Calle Mezquita, Edificio Velazquez, 11202 Algeciras (Cadiz), Spain

11. Validity

This notice is effective from the date of publication and may be modified at any time. Substantial modifications will be communicated to registered users at least 30 days in advance by email and by prominent publication on the platform.