Küsimused

Dear Ruth,

Thank You for Your inquiry.

SADE reporting method in Estonia is handled via our email address [email protected]

SADE reporting format is not specified. Generally, a .pdf file would be optimal.

All the best,

Merili Saar-Abroi on behalf of

Department of Medical Devices

State Agency of Medicines

[email protected]

1 Nooruse Street

50411 Tartu

Estonia

Phone: +372 737 4140

www.ravimiamet.ee

Dear Sir/Madam,

Hope this email finds you well.

Could you please confirm if the provided information (in green color) for medical devices in clinical trials in Estonia is correct?

               Domestic SADEs occurring within study (yes/no)?: Yes

               Foreign SADEs occurring within study (yes/no)?: Yes.

               SADEs from other studies with same study device / Cross-reports (yes/no)?: No.

               SADE Reporting Form: Clinical Investigation Summary Safety Report Form in MDCG 2020-10/2 rev.1.

               SADE Reporting Method: Please specify the reporting method (eg: email..)

               SADE Reporting Format: Please specify the reporting Format ( e.g: pdf, excel..)

               Electronic reporting destination: [email protected]

               Additional/Exceptions to expedited 7/15 SADE reports? (Yes/No): Yes.

               if yes, please see special reporting requirements:

- Serious public health threat: 2 days.
- Death or UNANTICIPATED serious deterioration in state of health: 7 days.
- Others: 30 days.

               Periodic Line Listing required? (Yes/no) if yes, please confirm: No

• * Frequency for Line Listing: NA

• * Reporting Timeline for Periodic Line Listing (days after DLP): NA

• * Periodic Line Listing Reporting Method (e.g. e-mail, N/A, etc.): NA.

• * Periodic Line Listing Format: NA

• * Destination for electronic Line Listing: NA

• * Annual Report required? (yes/no) if yes, please confirm: No.

• * Reporting Timeline for Annual Report (days after DLP): NA.

• * Annual Report Reporting Method (e.g. courier, CESP, email etc): NA.

• * Annual Report Reporting Format (e.g. paper, CD-ROM, pdf, eCTD etc): NA.

• * Destination for electronic Annual Report submission: NA.

• * Periodic Report Special reporting requirements: NA.

• * Translation required for safety reports?: NA

• * Translation requirements - Language and report/information to be translated? (if yes, please specify the language): NA.

Thank you in advance for your time and collaboration

Ruth Jiménez (She/Her)

Submissions Associate,

Patient Safety Solutions (PSS)

Upcoming Out of Office days: 17 and 18 April 2025

E: [email protected]

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