Keep your products in market after 1st of January 2021.
For hassle free UFI generation & PCN submission service click. HERE >>

BENS's Insider

How you can turn our experiences in your favor – free proffesional materials helping you implement best practices without hassle.

  • All
  • Safety Data Sheet
  • UFI / PCN
  • ADR
  • Biocides
  • REACH
  • Other
Recently by ""

Other | March 16, 2020

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.

 

 

Disclaimer:
Information on this blog is prepared with utmost care, but it is not about (chemical) consulting, and the provider does not assume any responsibility or liability for the correctness, accuracy and up-to-dateness of published content. If you need advice for a specific case, you can write to us at bojan.dimic@bens-consulting.com

Back to posts

X
To spletno mesto uporablja piškotke za namen izboljšave delovanja spletnega mesta. Več informacij najdete v naših pravilih o rabi piškotkov.