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Saatja: Jimenez, Ruth <[email protected]> Saaja: TA Info, MSO (Arhiiv) Teema: Safety reporting requirements in clinical investigations of medical devices in Estonia 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]> fortrea.com Fortrea Spain SAU Labcorp’s Clinical Development Business will become Fortrea ________________________________ Fortrea This 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