Classification UV-C and other room disinfectant devices as medical device?

Vetty007

Involved In Discussions
I wonder, if UV-C devices and other devices used for (room) disinfection purposes doesn't have to be medical devices. Disinfectants for disinfection of medical devices have to be medical devices too as stated separately in the MDR. Thus for me, as long as the device is used in the medical area, it has to be a medical device. But after checking several devices on the market,, I didn't find anyone, who's device is a medical device. When asking, why the device isn't a MD, the answer was only, that's not needed or more specific, that just the air is disinfected but not a device or that it's just Light, which they rated as very funny, that someones questions that just Light could require an approval. Crazy, that the MDR even adresses this as separate point in the GSPR :unsure:

Also I couldn't find an official statement about that or just found not helpful ones, which for sure was due to the special corona-time, during which one couldn't wait for MD approval of such systems. But back to normal, I am curious about your ideas/classification of UV-C devices or other devices (nebulizers) for Disinfection purposes in medical areas.
 

dgrainger

Trusted Information Resource
There is an entry in the MDD Borderlines manual that may be of use:

1.23. UV flow germicidal lamp
- Background:
UV flow germicidal lamps are intended to decrease the level of microbiological load in hospitals (operating rooms, treatment rooms, patient rooms, emergency room, isolation room and the refuse disposal site). These lamps are able to destroy bacteria, viruses, fungi, and other microorganisms. Contaminated air is drawn by a fan, through a filter that retains dust and other particles, into the disinfection chamber.
- Outcome:
Although maintaining clean air may contribute to keeping a patient in an appropriate environment, this is not considered to be a ‘medical purpose’. Also, these devices are not intended to be used for disinfecting medical devices but only for disinfecting air. Since these products do not fulfil the definition of a medical device or definition of accessory of medical device, they should not be qualified as such.


 

Vetty007

Involved In Discussions
Thank you for this very helpful reminder of the borderline manual, which I totally forgot, due to newer one, with only a few examples.

This is a good example, of a not that helpful guidance. But in turn to the argumentation, if the purpose isn't to disinfect air, but rather surfaces, replacing terminal disinfection with UV-C use, in my view still needs classification of such UV-C devices as device. Esp. if it is a device similar to a sterilizer, claimed for processing small devieces, which are certainly medical devices, and such devices are certainly not used privately....

The interesting question is, who is responsible for approval, in case a hospital uses a UV-C disinfection robot, that the manufacturer only advertises for general disinfection (meaning the air), but the hospital uses the device for final disinfection. Does the hospital then turn the device into a medical device and what consequences would that have?
 
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