| Dokumendiregister | Terviseamet |
| Viit | 11.2-1/24/1844-2 |
| Registreeritud | 15.02.2024 |
| Sünkroonitud | 27.03.2024 |
| 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 | 11.2-1/2023 |
| Juurdepääsupiirang | Avalik |
| Juurdepääsupiirang | |
| Adressaat | Qiagen |
| Saabumis/saatmisviis | Qiagen |
| Vastutaja | Sofia Ratušnaja (TA, Peadirektori asetäitja (1) vastutusvaldkond, Meditsiiniseadmete osakond) |
| Originaal | Ava uues aknas |
From: "Meditsiiniseadmed (Medical Devices)" <[email protected]>
Sent: Wed, 08 Nov 2023 15:57:39 +0000
To: CompetentAuthoritySubmissions <[email protected]>
Subject: Vs: SAE Reporting Procedure for an IVD Performance Study
Dear Mhairi,
Yes, the MDCG 2020-10 SAE Report Table is fine for IVD performance studies as well.
Submission of all kinds of documents related to medical devices can always be done via [email protected] until other sources (long waited Eudamed etc) will be available.
Best regards,
Sofia Ratušnaja
Chief Specialist
Medical Devices Department
+372 5661 5491
[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
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Saatja: CompetentAuthoritySubmissions <[email protected]>
Saatmisaeg: teisipäev, 31. oktoober 2023 11:20
Adressaat: Meditsiiniseadmed (Medical Devices) <[email protected]>
Teema: SAE Reporting Procedure for an IVD Performance Study
To Whom it May Concern,
I am looking to confirm the procedure for SAE reporting with respect to an IVD Performance study.
Can you advise which form (if applicable) should be used i.e., the MDCG 2020-10 SAE Report Table and to whom the form should be submitted to?
Thank you in advance for your help.
Kind Regards
Mhairi
Mhairi Coyle, PhD
Clinical Affairs Specialist, Global Clinical Affairs Operations
QIAGEN
Sample to Insight
QIAGEN Manchester Ltd (Remote)
[email protected]
www.qiagen.com
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