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Microwave medical waste disinfectant - A medical device or not?

ShRam

Starting to get Involved
#1
Hello folks,

I am working on a project which is for disinfecting medical wastes in hospitals using microwave. I have a doubt whether it comes under medical device. I have looked into a similar device which is ISO 13485 certified, so I guess it is a medical device but I’m not sure if the definition of medical device given in the EU MDR is really applicable to this product.

Kindly help me out.

Thanks in advance.
 
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planB

Super Moderator
#2
ShRam,

some additional questions:
  1. You only process waste, which is not intended to be used with human beings after being processed by your product?
  2. Do you claim for your product that you achieve an SAL (sterility assurance level) commensurate to a disinfection process or do you more generally "inactivate" or "decontaminate" medical waste?
 

ShRam

Starting to get Involved
#3
ShRam,

some additional questions:
  1. You only process waste, which is not intended to be used with human beings after being processed by your product?
  2. Do you claim for your product that you achieve an SAL (sterility assurance level) commensurate to a disinfection process or do you more generally "inactivate" or "decontaminate" medical waste?
Hi,

Yes we only process waste, decontaminate it for safe disposal
 

planB

Super Moderator
#4
Yes we only process waste, decontaminate it for safe disposal
Then you do not fall under the definition of a medical device per the MDR. Other (national) regulations will apply though.

Hope this helps,
 
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