Vastuskiri
| Dokumendiregister | Terviseamet |
| Viit | 11.1-12/24/5776-2 |
| Registreeritud | 03.06.2024 |
| Sünkroonitud | 04.06.2024 |
| Liik | Väljaminev 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: "Meditsiiniseadmed (Medical Devices)" <[email protected]>
Sent: Fri, 04 Aug 2023 08:21:04 +0000
To: "[email protected]" <[email protected]>
Subject: Vs: Can a medical device and a biocidal product be combined under one name?
Dear Maciej Borys,
Thank you for your inquiry.
Currently our position on these types of products is as follows: dual labelling is acceptable if the product fully complies with both regulations (MDR and biocide). The labelling and instructions for use of the product should easily distinguish instructions for the treatment of medical devices from instructions for biocides usages.
We recommend that claims corresponding to a biocidal status are clearly distinguished from those for a medical device status.
If you plan to place on the market/distribute any medical device in Estonia, all requirements have to be met, including the ones in the Medical Devices Act.
Best regards,
Egle Audova
Chief Specialist
Department of Medical Devices
Phone +372 5566 7596
[email protected] | [email protected]
| Republic of Estonia Health Board +372 794 3500 Paldiski mnt 81, 10614 Tallinn Estonia |
This e-mail is confidential and meant for use by the person named in the letterhead. Any use in any way or copying of it by a person not marked as the addressee thereof is prohibited. If you have got this e-mail by mistake, please notify of it the sender without delay and delete the received e-mail together with all its attachments.
Saatja: Maciej Borys <[email protected]>
Saatmisaeg: teisipäev, 1. august 2023 09:41
Adressaat: Meditsiiniseadmed (Medical Devices) <[email protected]>
Teema: 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
--
Pozdrawiam / Best Regards
Maciej Borys
Senior Regulatory Specialist
Karty charakterystyki dostępne są na stronie: SDS download
Seosed
| Nimi | K.p. | Δ | Viit | Tüüp | Org | Osapooled |
|---|---|---|---|---|---|---|
| Kiri | 03.06.2024 | 1 | 11.1-12/24/5776-1 | Sissetulev dokument | ta | Diversey |