Saatja: RA MSO </O=SOTSIAALMINISTEERIUM/OU=EXCHANGE ADMINISTRATIVE GROUP (FYDIBOHF23SPDLT)/CN=RECIPIENTS/CN=72F3C63240224E00B8EFA069E66B5C58-RA>
Saaja: Jimenez, Ruth, RA MSO
Teema: Vs: Safety reporting requirements in clinical investigations of medical devices in Estonia
Dear Ruth,
Thank You for Your inquiry.
SADE reporting method in Estonia is handled via our email address
[email protected] <mailto:
[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] <mailto:
[email protected]>
1 Nooruse Street
50411 Tartu
Estonia
Phone: +372 737 4140
www.ravimiamet.ee
Saatja: Jimenez, Ruth <
[email protected]>
Saatmisaeg: esmaspäev, 7. aprill 2025 16:28
Adressaat: TA Info <
[email protected]>; MSO (Arhiiv) <
[email protected]>
Teema: Safety reporting requirements in clinical investigations of medical devices in Estonia
Tähtsus: Kõrge
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 MDCG 2020-10/2 rev.1 <https://health.ec.europa.eu/document/download/bf136f27-27da-4a31-97c2-a5de741c3493_en?filename=md_mdcg_2020-10-2_guidance_safety_report_form_en.xlsx> .
· 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] <mailto:
[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] <mailto:
[email protected]>
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