Hi mates,

How to classify the medical devices for bio-diognastic product according to the Directive in EU? There is two type of bio-diognastic products here, which is drugs of abuse test and filariasis. Which route should go for and can the experts here explain how these routes go to?

:thanx:

TIffany

Hi mates,

How to classify the medical devices for bio-diognastic product according to the Directive in EU? There is two type of bio-diognastic products here, which is drugs of abuse test and filariasis. Which route should go for and can the experts here explain how these routes go to?

:thanx:

TIffany

Hi Tiffany,

I have changed the title of your thread to get more responses - pl let us know if its appropriate :)

Is ok. As long as I get some help from you mates here.

I am blurred with the classification here as one of the Notification Body giving information that these products is not belong to MDD nor IVDD under European Regulataion. In the meanwhile, there is another Notification Body giving information that this is under IVDD.

Where should I find the truth of it?

Tiffany
:(

Any takers for this ?