Does a medical device active (zinc oxide) needs BPR registration in EU?

[Cristina A]

I’m surprised that zinc oxide doesn’t appear as an approved active in BPR? If I would like to design a medical device containing zinc oxide? would I need BPR registration or DMF in active and CE mark on final device enough?

 

[planB]

Zinc oxide does not fall under the BPR: The latest substance evaluation can be found here. Also a zinc-oxide containing medical device does not fall under the BPR.

 

[PABSR]

Zinc oxide does not fall under the BPR: The latest substance evaluation can be found here. Also a zinc-oxide containing medical device does not fall under the BPR.

I would really appreciate if you could be more specific please? Why doesn't Zinc Oxide fall under the BPR (EU) 528/2012? Could you please include links if possible?
I need to report compliance to BPR (EU) 528/2012 of a rubber product that has Zinc Oxide in its mixing formulation (so it is mixed and cured in the final product)
Thank you!

 

[planB]

Have a look here (ZnO substance infocard) and here (search for biocidal substances and download of currently listed biocidal substances).

HTH,

 

[Vetty007]

It depends on the product and the function of the zincoxide in the formulation incl. the claims, but acc. to the given information the product should be sufficient to be a MD.

 

[PABSR]

Zinc Oxide is not listed in the ECHA Article 95 List, and I understand that is because its use is not authorized as component of a biocidal product.
If Zinc Oxide is not part of a biocidal product, (as in this case, it is part of an article and it is fully cured) then this regulation would not apply. As mentioned earlier by Vetty007, it depends on the function of the zinc oxide in the formulation. In my case it adds strength to the rubber compound.

Would this be correct? Thank you in advance.

 

[Vetty007]

Sorry for the late reply, but yes that is correct - would be different only if it adds an antimicrobial functionallity.