EU Regulations - Food (beverage used to mask the flavor of contrast agent)

J

Jackalope

#1
My apologies for using the Med Device forum, but it is the closest match I could find among the forums.

I have a question concerning a product that is used in conjunction with a medical device here in the US (beverage used to mask the flavor of contrast agent used with MRI or CAT scans). Here in the US it is not regulated by FDA. We would like to sell this in Europe. Can you point me toward the appropriate regulations? Have not had the opportunity to dig into European food regs as yet.

Much appreciated.
 
Elsmar Forum Sponsor

bio_subbu

Super Moderator
#2
My apologies for using the Med Device forum, but it is the closest match I could find among the forums.

I have a question concerning a product that is used in conjunction with a medical device here in the US (beverage used to mask the flavor of contrast agent used with MRI or CAT scans). Here in the US it is not regulated by FDA. We would like to sell this in Europe. Can you point me toward the appropriate regulations? Have not had the opportunity to dig into European food regs as yet.

Much appreciated.
The contrast agents used for “invivo” diagnosis are medicinal products (e.g. radiopharmaceuticals) and not medical devices. Refer under the section A.2.2.2 of the MEDDEV guidance 2.1/3 rev.3.

The beverage you refer to would therefore not be used in combination with a device but with a pharmaceutical.
 

Al Rosen

Staff member
Super Moderator
#3
My apologies for using the Med Device forum, but it is the closest match I could find among the forums.

I have a question concerning a product that is used in conjunction with a medical device here in the US (beverage used to mask the flavor of contrast agent used with MRI or CAT scans). Here in the US it is not regulated by FDA. We would like to sell this in Europe. Can you point me toward the appropriate regulations? Have not had the opportunity to dig into European food regs as yet.

Much appreciated.
Contrast agents, I believe, are regulated by FDA.
 
M

MIREGMGR

#4
How is your product administered...is this a drinkable substance that is given to the patient approximately synchronously with an injected contrast agent, to override the unpleasant taste sensation that results when the injected agent reaches the taste buds via the bloodstream? Or is this substance consumed after the contrast agent, both of which are drinkable? Or is there another administration method?

We don't actually need to know the specifics, but your question won't get good answers unless the product's regulatory context is understood.
 
J

Jackalope

#5
Thanks for the reply.

The contrast agent is added to the beverage and the resulting mixture is orally administered. Yes the contrast agent is regulated; however the beverage is not (in the US) and I am wondering what the regulatory status might be in the EU.

Thanks,
 
M

MIREGMGR

#6
Does the beverage have pharmaceutically regulated ingredients (even though, in the US, it's not FDA regulated as a drug), or food regulated ingredients?

Do you have product competitors within the EC market?

Is there a substantive technical difference between your product and, say, artificially flavored/sweetened/colored grape Koolaid?
 
J

Jackalope

#7
Ingredients typical beverage-type chemicals: sorbitol, mannitol, acidifiers, two artificial sweetners (sucralose and AceK), a few other standard things - nothing exotic. It seems like the food regs would apply.

Thanks,
 
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