Selgitustaotlus
| Dokumendiregister | Terviseamet |
| Viit | 11.3-3/24/3609-1 |
| Registreeritud | 04.04.2024 |
| Sünkroonitud | 05.04.2024 |
| Liik | Sissetulev 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
Tähelepanu! Tegemist on väljastpoolt asutust saabunud kirjaga. Tundmatu saatja korral palume linke ja faile mitte avada.
Hope this email finds you well.
We would like to confirm two topics related to pre-market device studies
in Estonia.
1. Could you please provide reference from MDR on the content of ASR
report for pre-market device study in Estonia?
2. 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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Saatja: Chevalier, Aleksandra <[email protected]>
Saadetud: 03.04.2024 17:55
Adressaat: TA Info <[email protected]>
Teema: ASR report for pre-market medical device study in Estonia query
Tähtsus: Kõrgeim
Dear Sir/Madam,
Hope this email finds you well.
We would like to confirm two topics related to pre-market device studies
in Estonia.
1. Could you please provide reference from MDR on the content of ASR
report for pre-market device study in Estonia?
2. 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: fortrea.comFortrea Development Ltd
________________________________
FortreaThis e-mail may contain confidential, proprietary, or protected
information - including protected health information - that is meant to
be viewed only by the intended recipient or company. Any unauthorized
review, use, copying, downloading or disclosure is strictly prohibited.
If this e-mail is not intended for you, or if you have received this e-
mail in error, please notify the sender immediately. Do not forward it to
any further recipients and permanently delete this e-mail and all
attachments. If you have questions or concerns, please see our privacy
policy on Fortrea.com
