Cristina A
Registered
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?
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?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.