Kiri
| Dokumendiregister | Terviseamet |
| Viit | 11.1-12/24/2437-1 |
| Registreeritud | 04.03.2024 |
| Sünkroonitud | 26.03.2024 |
| 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 | Medidee Services SA |
| Saabumis/saatmisviis | Medidee Services SA |
| Vastutaja | Karl Kalev Türk (TA, Peadirektori asetäitja (1) vastutusvaldkond, Meditsiiniseadmete osakond) |
| Originaal | Ava uues aknas |
Failid
From: Stivani Peto <[email protected]>
Sent: Fri, 15 Sep 2023 15:45:09 +0000
To: "[email protected]" <[email protected]>
Subject: [POSSIBLE SPAM]Custom made devices and EUDAMED compliance
|
Tähelepanu! Tegemist on väljastpoolt asutust saabunud kirjaga. Tundmatu saatja korral palume linke ja faile mitte avada. |
Hello,
I’m unsure whether I’ve reached the correct section however, I have some questions regarding custom made devices and EUDAMED compliance that I haven’t been able to find on your website.
- Custom made devices
As per MDR, custom made devices are made only after prescription from health care professional is issued. Requirements of who is considered as health care professional are not mentioned in MDR rather mentioned in national legislations. So my questions is:
- Who is considered as ‘health care professional’ and where is it stated in the national law?
- EUDAMED compliance
What is the method that is intended to be followed until EUDAMED is fully functional and becomes applicable mandatorily?
I hope that you can help me.
Kind regards,
Stivani
Seosed
| Nimi | K.p. | Δ | Viit | Tüüp | Org | Osapooled |
|---|---|---|---|---|---|---|
| Kiri | 04.03.2024 | 22 | 11.1-12/24/2437-2 | Väljaminev dokument | ta | Medidee Services SA |