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 and compliance with Infarmed mean the device is formally recognised for use in the Portuguese market, within the European framework.
Registration is not a decorative badge. It is proof that there is accountability, process, and traceability behind the product.
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 an immersive virtual reality therapy system registered as a Class I Medical Device (base product) with Infarmed, 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 and RVer Neuro modules are in development, 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.