VR in Portuguese Healthcare: What Is in Use and What INFARMED Requires

In Portugal, virtual reality in healthcare is no longer a demo. RVer, the immersive VR system we build, has passed 50,000 sessions in hospitals, clinics, continuing-care units and senior residences, and is registered with INFARMED as a Class I medical device under MDR (EU) 2017/745. This article brings together what we have learned: what it is used for, who runs the sessions, and what regulation asks for.

What it is used for today

In the institutions we work with, VR mostly appears in four situations:

• Pain: comfort and distraction during procedures, in oncology, burns units and after surgery.
• Anxiety: before exams and surgery, in paediatrics and in palliative care.
• Rehabilitation: motor and cognitive recovery exercises after a stroke, in neurology and in orthopaedics.
• Wellbeing: stimulation for older people, long hospital stays and isolation.

In every case it is a non-drug complement to care, always supervised. It does not treat, does not diagnose and does not replace medical care. What the evidence says, and where its limits are, is in does VR really reduce pain and anxiety? and does VR therapy work?

Who runs the session

It is the line we defend most: the session is always run by a health professional from the institution itself. The team chooses the content, runs the session, stops it when it needs stopping, and records it. The hardware is the least interesting part. That is also why we design from what clinical teams need rather than from what looks good in a demo; we explain those needs in what clinical teams need from a VR system.

Where it is already happening

Some public examples, all in the Leiria region, where the system started:

• Palliative Care at ULS Leiria: patients who travel without leaving their bed, a story told by SIC Notícias and Jornal de Leiria in 2024, and by the service itself in 2025.
• Alpedriz: older people looking out at the world through virtual reality, in 2022, in one of the first reports on the project.
• Training: in September 2026 we gave a certified training session on VR in rehabilitation at the School of Health of the University of Leiria and Oeste, invited by aTOPlab and the Occupational Therapy degree.

Links to each report are in the RVer case study.

What INFARMED requires

If a VR system is presented with a medical purpose (managing pain or anxiety, rehabilitation), it is a medical device and has to comply with Regulation (EU) 2017/745. For a Class I device like RVer there is no notified body: the manufacturer prepares the technical documentation, declares conformity and registers the device with the competent authority, which in Portugal is INFARMED.

In practice, that means having all of this before the first VR scene exists:

• an intended-use statement and a risk-management file;
• a documented software life cycle (IEC 62304) and usability validation (IEC 62366);
• clinical evaluation, a post-market surveillance plan and labelling a hospital can approve;
• deliberate, auditable, reversible updates instead of continuous releases.

We tell the full story in how we shipped a Class I medical VR device.

Where an institution should start

What we see work is starting small: one department, one concrete use (anxiety before an exam, for example) and one team that will run the sessions. Then there are three things that are not negotiable: reducing VR motion sickness, accessibility for people who are seated or bed-bound, and understanding the real cost, which we explain in what a VR therapy app costs.

RVer has its own website, rver.pt. If you are a healthcare institution in Portugal and want to know whether it makes sense for your team, talk to us.

FAQ

Does virtual reality replace pain medication?

No. It is a non-drug complement, used under the supervision of a health professional. It can help reduce pain and anxiety during a procedure, but it does not treat, does not diagnose and does not replace medical care.

Does a VR system for hospitals have to be a medical device?

If it is presented with a medical purpose, yes, and it has to comply with the MDR. A leisure 360° video in a headset is not a medical device; a system used to manage pain or for rehabilitation is.

Can older people use virtual reality?

Yes, with short, seated sessions and always accompanied. Someone wearing the headset can't see the room, so we tell them beforehand that they can take it off and stop at any moment. RVer is used in senior residences and in palliative care.