If you missed the first post on this topic, you can read it here.
Now, let’s go to the e-mail that came to us in response to this first post. Here’s a brief summary of the message:
“We sell hand sanitizers and surfaces in healthcare that are classified as medical devices.
It happens many times to us that customer also requires a sign up for the biocidal product register, which is not regulated for most of these assets.
How can we at the same time explain to the client that medical device legislation takes precedence in this case, and demonstrate that the device complies with their technical requirements?“
The question is extremely interesting and worth considering. Here’s what I answered:
“The distinction between medical devices and biocidal products is often problematic. Legislation overlaps at certain points, which means that the boundary between the two is very thin.
According to your product description - hand and surface disinfection - I would also consider the product to be biocide and not a medical device.
The same product cannot be listed as a medical device and biocide at the same time.
It is usually verified that a product with such a trade name is already in one register or another before it is entered in any of the registers.
You can provide the customer with proof of entry in the medical device registry and explain the difference to them. I do not know the technical requirements of your clients, but I conclude that proof of entry in the register of medical devices should be sufficient. You can also prepare a performance statement that covers the results of studies for each target organism.
I hope the above helps you.”
If you think that this post could be useful for anyone else, please share it with them. If you have any further questions, you can send it over to me.
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