There are many virtual reality apps today that promise relaxation or distraction. But using technology in a clinical environment raises a different question: does this solution meet the requirements of a medical device? The answer separates a consumer product from a tool fit to be part of healthcare.
What Class I means under MDR 2017/745
The MDR 2017/745 is the European Union's Medical Device Regulation. It classifies devices by risk level, from Class I (lowest) to Class III (highest). Class I covers devices with low risk to the user, but "low risk" does not mean "no requirements".
Even in Class I, the manufacturer must:
- Maintain complete technical documentation of the device.
- Implement a risk management system.
- Ensure post-market surveillance and traceability.
- Register the device with the competent authority.
The role of Infarmed
In Portugal, Infarmed is the national authority for medical devices. Registration with Infarmed means the device and its manufacturer are identified to the Portuguese authority, within the European framework. It is not an approval or a certification.
Registration is not a decorative badge. It is proof that there is accountability, process, and traceability behind the product.
EUDAMED
EUDAMED is the European database on medical devices set up under MDR 2017/745. Registration in EUDAMED is not an approval: it makes the identification of the device and of the manufacturer searchable across the European Union. Since October 2026, the RVer base product has been registered in EUDAMED, under Basic UDI-DI 56006195127RVERTZ.
Why this matters for a hospital
When choosing technology for a healthcare service, the procurement team and clinical professionals need guarantees that a store app does not offer:
- Safety: the device has been assessed for risks to the patient.
- Accountability: there is an identified manufacturer responsible for compliance.
- Traceability: there is a process to report and resolve incidents.
- Institutional trust: it eases integration in regulated contexts.
RVer and compliance by design
RVer is a virtual reality system for clinical use registered as a Class I Medical Device (base product) in EUDAMED and with INFARMED (Portugal), bearing the CE mark under MDR 2017/745. It was built for the healthcare context from the start, including an important privacy decision: it does not collect patient clinical data. In RVer's case, the registration covers the base product: the video library. The RVer Motion, RVer Neuro and RVer Exposure modules are in development and not covered by that registration, and the base product bears the CE mark under MDR 2017/745.
For a hospital or clinic, this translates into a tool that can be adopted with the confidence that it meets the applicable regulatory framework.
Frequently asked questions
What is a Class I Medical Device?
It is the lowest risk class of medical devices under the European MDR 2017/745 regulation. It covers devices with low risk to the user that must still meet safety, quality, and compliance requirements and be registered with the competent authority.
What does registration with Infarmed mean?
It means the device and its manufacturer are registered with the Portuguese authority and that the manufacturer meets the MDR requirements: it maintains technical documentation, risk management, and post-market surveillance, and that the device is registered for use in Portugal. The registration applies to the device as registered: in RVer's case, to the base product.
Why does this matter when choosing VR technology for healthcare?
Registration as a medical device identifies the manufacturer and the device, and requires safety, traceability and accountability obligations that a consumer app does not have, which is essential in a clinical context.