Vastuskiri
| Dokumendiregister | Terviseamet |
| Viit | 11.1-12/24/1244-2 |
| Registreeritud | 31.01.2024 |
| Sünkroonitud | 27.03.2024 |
| 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 | Becton, Dickinson and Company |
| Saabumis/saatmisviis | Becton, Dickinson and Company |
| Vastutaja | Merili Saar (TA, Peadirektori asetäitja (1) vastutusvaldkond, Meditsiiniseadmete osakond) |
| Originaal | Ava uues aknas |
Failid
From: "Meditsiiniseadmed (Medical Devices)" <[email protected]>
Sent: Fri, 06 Oct 2023 12:38:48 +0000
To: Barbara Björkbom <[email protected]>
Subject: Vs: eIFU for IVDs
Dear Ms. Björkbom
Thank You for Your e-mail.
Regulation (EU) 2017/746 of the European Parliament and of the Council, point (f) of Section 20.1 of Annex I states that:
„When the device is intended for professional use only, instructions for use may be provided to the user in non-paper format (e.g. electronic), except when the device is intended for near-patient testing.“
Please refer to the Regulation (EU) 2017/746 for any further information regarding this topic.
All the best,
Merili Saar
peaspetsialist
meditsiiniseadmete osakond
+372 554 3041
| Terviseamet +372 794 3500 [email protected] Paldiski mnt 81, 10614 Tallinn |
Käesolev kiri on konfidentsiaalne ning mõeldud kasutamiseks kirja päises nimetatud isikule/asutusele. Käesoleva kirja mistahes viisil kasutamine või kopeerimine isiku poolt, kes ei ole märgitud selle adressaadiks, on keelatud. Kui te olete saanud käesoleva kirja ekslikult, palume sellest koheselt teavitada kirja saatjat ning kustutada saadud kiri koos kõikide lisadega.
Saatja: Barbara Björkbom <[email protected]>
Saatmisaeg: reede, 6. oktoober 2023 09:00
Adressaat: Meditsiiniseadmed (Medical Devices) <[email protected]>
Teema: eIFU for IVDs
Tähelepanu! Tegemist on väljastpoolt asutust saabunud kirjaga. Tundmatu saatja korral palume linke ja faile mitte avada. |
Dear Sir/Madam,
I am contact you in regards to the acceptance of eIFU in Estonia
Is acceptable only eIFU for IVDs for professional use devices (e.g. equipment and assay to be run on it) that are going to be use by lab technicians.
I thank you in advance for your support!
Best regards,
Barbara Björkbom
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Seosed
| Nimi | K.p. | Δ | Viit | Tüüp | Org | Osapooled |
|---|---|---|---|---|---|---|
| Kiri | 31.01.2024 | 56 | 11.1-12/24/1244-1 | Sissetulev dokument | ta | Becton, Dickinson and Company |