Zinc Oxide as a Topical Application

[Dr RA]

Hi
Has anyone come across Zinc Oxide cream/ointment/spray/emollient as Class I or III medical device of MDD.

Rule 13 indicates it as class III, how does it qualify as class I.

Many Thanks
RA

 

[SteveK]

Re: Zinc oxide topical application

I don't know if this helps or muddies the waters, but have you looked at:

Manual on Borderline and Classification in the Community regulatory framework for medical Devices

http://ec.europa.eu/DocsRoom/documents/12867/attachments/1/translations

Section:

4.6. Zinc oxide containing creams

Steve

 

[Dr RA]

Thanks Steve, I have already looked at the Borderline manual, it further confuses as rightly mentioned by you.

 

[chris1price]

It comes down to the mechanism by which the zinc oxide acts. If it acts primarily as a barrier to stop bacteria passing or skin being scratched, then it is a medical device. However, if it has a pharmacological action then it is a medicine. If it does both (barrier and pharacological actions) then it is a medicine.

So you woulkd need to look carefuly at the indications, claims, etc of the product to determine the primary action.

It could only be Class 1 if it acted as a bandage and had no medicinal action whatsoever.

Chris

 

[Dr RA]

Thank you Chris1price, I have raised the question to NB's with the same statement mentioned by you on claim of the product.

Thanks again
RA