Are commercial VR headsets and computers considered medical device accessories under MDR when sold as a system with SaMD?

Question

At our company, we develop software for cognitive assessments that requires a virtual reality (VR) headset (such as an HP headset) and a computer to operate. The software is compatible with various commercial headsets, but our business model is to market the system as a bundle: headset, computer, and software sold together.

I would like to clarify the regulatory expectations under the EU Medical Device Regulation (MDR):
• If we sell the software, headset, and computer as a system, would the headset and computer be considered medical device accessories?
• What responsibilities would we have regarding the headset, particularly in terms of compliance and modifications?
• Are we required to conduct electromagnetic compatibility (EMC) tests on the headset and computer?
• If the headset is not manufactured by us and we cannot modify it, should we notify the manufacturer (e.g., HP) that their product is being used for a medical purpose?

I have received different opinions from consultants, so I would appreciate insights or references to applicable MDR requirements.

Dr. Oliver Eidel · Accepted Answer

If you're selling the software, headset, and computer as a system for a medical purpose in the EU, you're likely falling under MDR Article 22, which covers 'systems and procedure packs.' This means you're responsible for making sure all combined products are compatible for their intended medical use and are used within the limits set by their manufacturers. Even if the headset and computer are not medical devices or accessories by themselves, bringing them together as a system for a medical purpose creates some obligations.

Specifically, you would need to:
• Demonstrate compatibility and justify the inclusion of each component in the system.
• Draw up a statement as required by Article 22, detailing conformity and appropriate use.
• Ensure that the non-medical device parts (like the headset and computer) comply with applicable legislation (e.g., CE marking for electronics).

Regarding EMC testing, you should evaluate whether the combined system introduces risks not covered by the original CE marking of the headset and computer. If your intended use or configuration could affect EMC, additional testing may be required. Your responsibility is to ensure safe and effective operation for the intended medical purpose.

As for notifying the headset manufacturer, it's not explicitly required under MDR, but it's good practice to inform them that their product is being used in a medical context, especially if you encounter technical issues or need support.

Bottom line: Document everything—compatibility, risk assessments, intended use, and any testing you perform. If in doubt, consult with a notified body or a regulatory expert familiar with MDR Article 22.

Are commercial VR headsets and computers considered medical device accessories under MDR when sold as a system with SaMD?

1 Answer

Keep reading

Is internally used diagnostic software considered a medical device under MDR?

In-House Devices Under The MDR

MDD Essential Requirements