Vastuskiri
| Dokumendiregister | Terviseamet |
| Viit | 11.2-1/24/12874-2 |
| Registreeritud | 17.12.2024 |
| Sünkroonitud | 18.12.2024 |
| Liik | Väljaminev dokument |
| Funktsioon | 11.2 Turustamise eelne järelevalve (pre-marketing surveillance) |
| Sari | 11.2-1 Meditsiiniseadmete kliiniliste uuringute ja toimivusuuringute dokumendid (taotlused, load, muud teavitused ja kirjavahetus) |
| Toimik | 11.2-1/2024 |
| Juurdepääsupiirang | Avalik |
| Juurdepääsupiirang | |
| Adressaat | Qmed Consulting |
| Saabumis/saatmisviis | Qmed Consulting |
| Vastutaja | Merili Saar-Abroi (TA, Peadirektori asetäitja (1) vastutusvaldkond, Meditsiiniseadmete osakond) |
| Originaal | Ava uues aknas |
Failid
From: "Meditsiiniseadmed (Medical Devices)" <mso@terviseamet.ee>
Sent: Thu, 05 Dec 2024 14:51:25 +0000
To: Eva Dahlberg <eda@qmed-consulting.com>
Subject: Vs: MDR article 82
Dear Ms. Dahlberg,
The requirements for MDR article 82 studies are described in the Estonian Medical Devices Act § 221 as follows:
“In the event of investigations specified in Article 82 of Regulation (EU) 2017/745 of the European Parliament and of the Council, the requirements provided for in subsections 2-7 of Article 62 and in Articles 63-66, 68-72, 75-77 and 80 are applied except for in those aspects concerning the submission of documents and exchange of information through the electronic system specified in Article 73 and the requirement to prepare a clinical assessment plan.“
Therefore, an authorisation of the Health Board is required.
Merili Saar-Abroi
Chief Specialist
Department of Medical Devices
Phone +372 554 3041
merili.saar-abroi@terviseamet.ee | mso@terviseamet.ee
| Terviseamet | Health Board +372 794 3500 info@terviseamet.ee Paldiski mnt 81, 10614 Tallinn |
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: Eva Dahlberg <eda@qmed-consulting.com>
Saatmisaeg: neljapäev, 5. detsember 2024 11:45
Adressaat: Meditsiiniseadmed (Medical Devices) <mso@terviseamet.ee>
Teema: MDR article 82
Tähelepanu! Tegemist on väljastpoolt asutust saabunud kirjaga. Tundmatu saatja korral palume linke ja faile mitte avada. |
Dear Health Board,
In relation to a data collection study under MDR article 82, the sponsor does not need to notify the Health Board however, a positive opinion needs to be obtained from the ethical committee. May I please ask you to confirm.
Thank you.
|
Seosed
| Nimi | K.p. | Δ | Viit | Tüüp | Org | Osapooled |
|---|---|---|---|---|---|---|
| Kiri | 17.12.2024 | 1 | 11.2-1/24/12874-1 | Sissetulev dokument | ta | Qmed Consulting |