Subject: Safety reporting requirements in clinical investigations of medical devices in Estonia
From: "Jimenez, Ruth" <[email-masked]>
To: <[email-masked]>, <[email-masked]>
Date: Mon, 7 Apr 2025 16:27:35 +0300

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

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
<https://health.ec.europa.eu/document/download/bf136f27-27da-4a31-97c2-a5d
e741c3493_en?filename=md_mdcg_2020-10-2_guidance_safety_report_form_en.xls
x> 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:
<mailto:[email-masked]> [email-masked]

·             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:  <mailto:[email-masked]> [email-masked]

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