Küsimused

Dear Irbe Šmite,

 

It would seem more probable that this product would fall under the medicinal product regulation. This would however be the responsibility of the manufacturer to determine the correct regulatory status of their product in accordance with all relevant regulations. And that would dictate all other rules to be followed when distributing it.

 

For information, in addition to general definitions on medical devices and medicinal products readily available in public legal acts, I will more specifically bring to your attention these sections from regulation (EU) 2017/745:

 

8.   Any device which, when placed on the market or put into service, incorporates, as an integral part, a substance which, if used separately, would be considered to be a medicinal product as defined in point 2 of Article 1 of Directive 2001/83/EC, including a medicinal product derived from human blood or human plasma as defined in point 10 of Article 1 of that Directive, and that has an action ancillary to that of the device, shall be assessed and authorised in accordance with this Regulation.

However, if the action of that substance is principal and not ancillary to that of the device, the integral product shall be governed by Directive 2001/83/EC or Regulation (EC) No 726/2004 of the European Parliament and of the Council ( ¹ ), as applicable. In that case, the relevant general safety and performance requirements set out in Annex I to this Regulation shall apply as far as the safety and performance of the device part are concerned.

9.   Any device which is intended to administer a medicinal product as defined in point 2 of Article 1 of Directive 2001/83/EC shall be governed by this Regulation, without prejudice to the provisions of that Directive and of Regulation (EC) No 726/2004 with regard to the medicinal product.

However, if the device intended to administer a medicinal product and the medicinal product are placed on the market in such a way that they form a single integral product which is intended exclusively for use in the given combination and which is not reusable, that single integral product shall be governed by Directive 2001/83/EC or Regulation (EC) No 726/2004, as applicable. In that case, the relevant general safety and performance requirements set out in Annex I to this Regulation shall apply as far as the safety and performance of the device part of the single integral product are concerned.

 

Best regards,

 

Piret Põiklik
Head of Department

Department of Medical Devices
State Agency of Medicines

[email protected]
+372 5853 3610

1 Nooruse Street
50411 Tartu
Estonia
Phone: +372 737 4140

www.ravimiamet.ee

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From: Irbe Smite <[email protected]>
Sent: Thursday, November 20, 2025 11:36 AM
To: Ravimiamet <[email protected]>
Subject: Question to Piret Poiklik: New medical device including atropine in dry format by KALEO

 

Tähelepanu! Tegemist on väljastpoolt asutust saabunud kirjaga. Tundmatu saatja korral palume linke ja faile mitte avada.

 

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,

Irbe Šmite
Export and Market Intelligence Project Coordinator

Gateway & Partners - Your Export Powerhouse

Mobile: +371 251 361 64

@: [email protected]

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