Vastuskiri
| Dokumendiregister | Terviseamet |
| Viit | 11.3-3/24/3609-2 |
| Registreeritud | 08.04.2024 |
| Sünkroonitud | 09.04.2024 |
| Liik | Väljaminev dokument |
| Funktsioon | 11.3 Meditsiiniseadmete alane koostöö Euroopa komisjoni, sõsarasutuste, ministeeriumide ja teiste ametite/inspektsioonidega |
| Sari | 11.3-3 Üldine kirjavahetus (Koostöö riigiasutustega (ministeeriumid, ametid, inspektsioonid, jms) |
| Toimik | 11.3-3/2024 |
| Juurdepääsupiirang | Avalik |
| Juurdepääsupiirang | |
| Adressaat | Fortrea Development OÜ |
| Saabumis/saatmisviis | Fortrea Development OÜ |
| Vastutaja | Sofia Ratušnaja (TA, Peadirektori asetäitja (1) vastutusvaldkond, Meditsiiniseadmete osakond) |
| Originaal | Ava uues aknas |
Failid
From: "Meditsiiniseadmed (Medical Devices)" <[email protected]>
Sent: Mon, 08 Apr 2024 10:14:50 +0000
To: "Chevalier; Aleksandra" <[email protected]>
Subject: Vs: ASR report for pre-market medical device study in Estonia query
Dear Aleksandra Chevalier,
Could you please specify, what do you mean by ASR report? There is no such a term in MDR. There are reporting obligations in the end or termination of clinical investigation (Art 77) and in case of adverse events (Art 80).
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
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Saatja: Chevalier, Aleksandra <[email protected]>
Saatmisaeg: kolmapäev, 3. aprill 2024 17:56
Adressaat: TA Info <[email protected]>
Teema: ASR report for pre-market medical device study in Estonia query
Tähtsus: Kõrge
Dear Sir/Madam,
Hope this email finds you well.
We would like to confirm two topics related to pre-market device studies in Estonia.
- Could you please provide reference from MDR on the content of ASR report for pre-market device study in Estonia?
- Our Sponsor have decided to have 1 ASR per product per protocol per country. Could you please verify/confirm there is no regulation in Estonia or Europe (MDR 745-20017 requirement) against this decision?
Thank you
Best Regards,
Aleksandra Chevalier, MPharm
Drug Safety Associate, Drug Safety
E: [email protected]
fortrea.com
Fortrea Development Ltd
Fortrea
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