Infokiri

Dokumendiregister	Terviseamet
Viit	5-7/25/432-1
Registreeritud	11.06.2025
Sünkroonitud	12.06.2025
Liik	Sissetulev dokument
Funktsioon	5 Teabe- ja arhiivihaldus
Sari	5-7 Teabenõuded, selgitustaotlused, märgukirjad (sh avaldused, kaebused, taotlused jm pöördumised)
Toimik	5-7/2025
Juurdepääsupiirang	Avalik
Juurdepääsupiirang
Adressaat	Roche Diagnostic Solutions
Saabumis/saatmisviis	Roche Diagnostic Solutions
Vastutaja	Liivi Zovo
Originaal	Ava uues aknas

Failid

D194544_mdcg_2024-4_RD006691_10Jun2025.xlsm

E-kiri.eml

D194544_mdcg_2024-4_RD006691_10Jun2025.xlsm

E-kiri.eml

Tähelepanu! Tegemist on väljastpoolt asutust saabunud kirjaga. Tundmatu saatja korral palume linke ja faile mitte avada.

Dear Sir/Madam,

Please find attached an IVD SAE Report form (IVDR Performance Study Summary Safety Reporting Form MDCG 2024-4 Appendix) for the IVD Performance Evaluation with PSP code RD006691.

The SAE is related to a study procedure (sample collection) occurring outside Estonia, and does not directly involve patients in Estonia. Testing with the IVD device occurred in Edinburgh, Scotland. The event is reported as the study procedures and testing are conducted under the same IVD protocol that will be used for Estonian patients. The device manufacturer causality assessment has found that the SAE was not related to the device.

Please advise if any additional information is required.

Kind regards,

Rachael Sobczak

Global Studies Leader

IQVIA Agent representing Roche Diagnostic Solutions

Mobile: 317-965-7205

Email: [email protected]

Upcoming OOO: N/A