Küsimused

Dear Piret, 

I spoke to your colleague, and they said you would be the best person who could help me with a question regarding a new type of medical device. 

I am working with a client, KALEO (https://kaleo.com/partnering/#medicalcountermeasures) from the US, and they are looking for distributors in Estonia. They have developed a medical device called AERIO for the use of soldiers in combat, it is a plastic casing with injectable atropine in dry format inside. It can be used in cases where there are toxic gas attacks like Sarin.

I have a couple of questions, as they are thinking of approaching military equipment distributors, whereas I am thinking that due to the atropine being in this device, this would be classified more as a drug and pharmaceutical-related product.

My questions are the following:

1. Would a medical device with atropine in dry format be classified as a device or as a drug-related product?

2. For this type of product to be distributed in Estonia, would KALEO be able to talk to any distributor (military equipment, for example), or ONLY companies that hold drug-distribution certification given to them by your Agency?

I really appreciate your insight!

Thank you,