Vastuskiri
| Dokumendiregister | Terviseamet |
| Viit | 11.1-12/24/544-2 |
| Registreeritud | 17.07.2024 |
| Sünkroonitud | 18.07.2024 |
| Liik | Väljaminev dokument |
| Funktsioon | 11.1 Turustamise järgne järelevalve (post-marketing surveillance) |
| Sari | 11.1-12 Turujärelevalvega seotud muu kirjavahetus („tahetakse infot“) - Nõustamine |
| Toimik | 11.1-12/2024 |
| Juurdepääsupiirang | Avalik |
| Juurdepääsupiirang | |
| Adressaat | BTI BIOTECHNOLOGY INSTITUTE |
| Saabumis/saatmisviis | BTI BIOTECHNOLOGY INSTITUTE |
| Vastutaja | Karl Kalev Türk (TA, Peadirektori asetäitja (1) vastutusvaldkond, Meditsiiniseadmete osakond) |
| Originaal | Ava uues aknas |
Failid
From: "Meditsiiniseadmed (Medical Devices)" <[email protected]>
Sent: Wed, 17 Jul 2024 10:20:50 +0000
To: "[email protected]" <[email protected]>
Subject: Vs: National requirements for medical devices
Dear Nerea Nieto,
Thank you for your inquiry.
Even though you wrote to the Estonian Medicines Agency, the answer is from the Health Board, which is the competent authority for medical devices in Estonia.
While the question is not specifically about medical device requirements but rather about the requirements for healthcare professionals regarding the reprocessing of medical devices, we believe that we are not the correct department to provide answers. However, after consulting, we understand that there are no specific national requirements different from the MDR set in Estonia. Therefore, since we may not be the appropriate authority to address this issue, we recommend not taking our answer as definitive.
There is also the Estonian Dental Association in Estonia, which has published a non-binding guideline, "Hygiene Requirements in Dentistry," that covers sections like "Decontamination of instruments and accessories" (5.2) and "Sterilization, washing, disinfection of instruments, and use of washing machine" (5.3). Although the whole guide is in Estonian, it might give you some insight with the help of translation tool.
Best regards,
Karl Kalev Türk
Chief Specialist
Department of Medical Devices
Phone +372 5648 5663
[email protected] | [email protected]
| Republic of Estonia Terviseamet | Health Board +372 794 3500 [email protected] 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.
From: Nerea Nieto <[email protected]>
Sent: neljapäev, 11. juuli 2024 15:08
To: Ravimiamet <[email protected]>
Subject: National requirements for medical devices
Tähelepanu! Tegemist on väljastpoolt asutust saabunud kirjaga. Tundmatu saatja korral palume linke ja faile mitte avada. |
Good morning,
My name is Nerea Nieto, and I am a Regulatory Affairs Technician at BTI BIOTECHNOLOGY INSTITUTE.
BTI is a Spanish manufacturer of dental related medical devices. Our devices are CE marked and comply with MDD or MDR medical device regulations.
We commercialize our devices in the EU including your country.
We have a question regarding requirements in Estonia on reusable devices requiring appropriate cleaning, disinfection and sterilization procedures by health professionals before use.
Currently, for these devices BTI provides the user with instructions for use with an appropriate protocol for cleaning, disinfection and sterilization procedures.
These procedures have been validated according to international standards UNE-EN ISO 17665-1:2007 and EN ISO 17664-1:2021.
We would appreciate if you could provide us with the following information:
- Are there specific national requirements in your country for the (re)processing (i.e. proper cleaning, disinfection and sterilization) of medical devices, different from those set by the MDR or the international standards mentioned above?
-If so, could you please provide us with the corresponding legislation or guidelines?
P.S. I would be grateful if this email could be forwarded to the relevant person/department.
Thanks in advance for your help.
Best regard,
|
| Nerea Nieto Ulibarri Regulatory Affairs Department Parque Tecnológico de Álava |
No me imprimas si no es necesario. Protejamos el medio ambiente |
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