Saatja: RA MSO </O=SOTSIAALMINISTEERIUM/OU=EXCHANGE ADMINISTRATIVE GROUP (FYDIBOHF23SPDLT)/CN=RECIPIENTS/CN=72F3C63240224E00B8EFA069E66B5C58-RA>
Saaja:
[email protected], RA MSO
Teema: Vs: Clarification on Regulation of Veterinary IVD Medical Devices
Dear Christelle,
Thank You for Your inquiry.
Legislation and standards regarding human medical devices are generally not applicable to veterinary medical devices. However, should You use a medical device intended for human use in a veterinary context instead, the human medical device must still comply with all relevant legislation for human medical devices, regardless of its application in veterinary care only.
In Your case, these would mainly include Regulation (EU) 2017/746 for in vitro diagnostic medical devices and the Estonian Medical Devices Act.
Regarding registration of (human) medical devices, the Estonian Medical Devices Act <https://www.riigiteataja.ee/en/eli/ee/515032023005/consolide/current> § 26 (4) states that every undertaking who distributes on the market of Estonia a class B, C or D in vitro diagnostic medical device classified according to Annex VIII of Regulation (EU) 2017/746 concerning in vitro diagnostic medical devices, shall notify the State Agency of Medicines thereof within 10 days after distribution of the relevant medical device for the first time. The State Agency of Medicines can be notified via Estonian Medical Device Database <https://msa.sm.ee/ctrl/en/Avaleht/index/?> (EMDDB). There are no fees for registering (human) medical devices in the EMDDB.
In case Your device is only intended for veterinary use, legislations regarding human medical devices do not apply. For further information a consultation with the Estonian Agriculture and Food Board <https://pta.agri.ee/en> via
[email protected] <mailto:
[email protected]> is advised.
In case of any further questions, please do not hesitate to contact us again.
All the best,
Merili Saar-Abroi on behalf of
Department of Medical Devices
State Agency of Medicines
[email protected] <mailto:
[email protected]>
1 Nooruse Street
50411 Tartu
Estonia
Phone: +372 737 4140
www.ravimiamet.ee
From: Christelle Calvo <
[email protected] <mailto:
[email protected]> >
Sent: esmaspäev, 5. mai 2025 16:43
To: Ravimiamet <
[email protected] <mailto:
[email protected]> >
Subject: Clarification on Regulation of Veterinary IVD Medical Devices
Tähelepanu! Tegemist on väljastpoolt asutust saabunud kirjaga. Tundmatu saatja korral palume linke ja faile mitte avada.
Dear Madam,
Dear Sir,
I would like to obtain confirmation please regarding the regulation of veterinary in vitro diagnostic (IVD) medical devices.
Our interpretation is that veterinary IVD medical devices are not specifically regulated in Europe as they are out of scope of the IVD Regulation 2017/746.
Here is my question: I would like to know if an IVD medical device that performs a complete blood count (blood test measuring amounts and sizes of various blood cells: red blood cells, white blood cells, hemoglobin, platelets) on an animal's blood sample is covered by any national law in your country ?
Thank you in advance for your assistance.
Christelle Calvo
Regulatory Affairs Specialist
HORIBA ABX SAS
398, rue du Caducée
34790 Grabels - FRANCE
Phone +33 (0)4 67 14 15 76
www.horiba.com/medical <http://www.horiba.com/medical/>
[email protected] <mailto:
[email protected]>