Kiri
| Dokumendiregister | Terviseamet |
| Viit | 11.1-12/24/5776-1 |
| Registreeritud | 03.06.2024 |
| Sünkroonitud | 04.06.2024 |
| Liik | Sissetulev dokument |
| Funktsioon | 11.1 Turustamise järgne järelevalve (post-marketing surveillance) |
| Sari | 11.1-12 Turujärelevalvega seotud muu kirjavahetus („tahetakse infot“) - Nõustamine |
| Toimik | 11.1-12/2023 |
| Juurdepääsupiirang | Avalik |
| Juurdepääsupiirang | |
| Adressaat | Diversey |
| Saabumis/saatmisviis | Diversey |
| Vastutaja | Egle Audova (TA, Peadirektori asetäitja (1) vastutusvaldkond, Meditsiiniseadmete osakond) |
| Originaal | Ava uues aknas |
Failid
From: Maciej Borys <maciej.borys@diversey.com>
Sent: Tue, 01 Aug 2023 06:40:44 +0000
To: mso@terviseamet.ee
Subject: Can a medical device and a biocidal product be combined under one name?
|
Tähelepanu! Tegemist on väljastpoolt asutust saabunud kirjaga. Tundmatu saatja korral palume linke ja faile mitte avada. |
Dear Sir/Madam,
My name is Maciej Borys, and I'm represeting a manufacturer of Biocides and Class IIa Medical Devices. Company is located in the EU.
The same product formulation can be used to disinfect a surface (Biocide) or to disinfect a Medical Device (Class IIa Medical Device).
Some authorities and notified bodies accept the combined use of Biocide and Medical Device (disinfection) in the same product.
However, some other authorities or notified bodies do not.
I would like to ask a question about Medical devices to be placed on the Estonian market in the future.
Is there a possibility of combining the Biocide/Medical device intended use? In other words can a Biocidal Product also be a Medical Device?
Or should a product be sold under two separate names with separate uses, One as a biocidal product and the other notified as a Medical Device?
Thank you very much in advance,
Best Regards,
Maciej Borys
Seosed
| Nimi | K.p. | Δ | Viit | Tüüp | Org | Osapooled |
|---|---|---|---|---|---|---|
| Vastuskiri | 03.06.2024 | 1 | 11.1-12/24/5776-2 | Väljaminev dokument | ta | Diversey |