Küsimused
| Dokumendiregister | Ravimiamet |
| Viit | MSO-8/2300-1 |
| Registreeritud | 06.05.2025 |
| Sünkroonitud | 07.05.2025 |
| Liik | Sissetulev kiri |
| Funktsioon | MSO Meditsiiniseadmed |
| Sari | MSO-8 Turujärelevalvega seotud nõustamine |
| Toimik | MSO-8/2025 |
| Juurdepääsupiirang | Avalik |
| Juurdepääsupiirang | |
| Adressaat | HORIBA ABX SAS |
| Saabumis/saatmisviis | HORIBA ABX SAS |
| Vastutaja | Merili Saar-Abroi (RA, Meditsiiniseadmete osakond) |
| Originaal | Ava uues aknas |
Failid
From: Kärolin Jenas <[email protected]>
Sent: Mon, 05 May 2025 14:20:01 +0000
To: RA MSO <[email protected]>
Subject: FW: Clarification on Regulation of Veterinary IVD Medical Devices
From: Christelle Calvo <[email protected]>
Sent: esmaspäev, 5. mai 2025 16:43
To: Ravimiamet <[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 |
|
|
www.horiba.com/medical [email protected]
Seosed
| Nimi | K.p. | Δ | Viit | Tüüp | Org | Osapooled |
|---|---|---|---|---|---|---|
| Küsimused | 06.05.2025 | 1 | MSO-8/2300-2 | Väljaminev kiri | ra | HORIBA ABX SAS |