Küsimused

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 § 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 (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 via [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]

1 Nooruse Street

50411 Tartu

Estonia

Phone: +372 737 4140

www.ravimiamet.ee

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

www.horiba.com/medical      [email protected]