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Saatja: RA MSO </O=SOTSIAALMINISTEERIUM/OU=EXCHANGE ADMINISTRATIVE GROUP (FYDIBOHF23SPDLT)/CN=RECIPIENTS/CN=72F3C63240224E00B8EFA069E66B5C58-RA> Saaja: Martello, Daiana, SPVG Regulatory Intelligence, RA MSO Teema: Vs: Clinical investigations with Medical Devices - Safety reporting email address Dear Mrs. Martello, Thank You for Your inquiry. We confirm that the email address to submit safety reports arising from Clinical Investigations with Medical Devices is [email protected] <mailto:[email protected]> 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: Martello, Daiana <[email protected]> Saatmisaeg: esmaspäev, 10. märts 2025 13:02 Adressaat: RA MSO <[email protected]> Koopia: SPVG Regulatory Intelligence <[email protected]> Teema: Clinical investigations with Medical Devices - Safety reporting email address Dear Sir/Madam, I am a Safety Specialist at Syneos Health (Clinical Research Organization), a company responsible for Safety reporting on behalf of Sponsors in the frame of Clinical Investigations with Medical Devices and In Vitro Diagnostics (IVDs). In the context of the announcement published on 1 January 2025 on the Ravimiamet website (link <https://ravimiamet.ee/uudised/2025-aastal-tuuakse-meditsiiniseadmete-valdkonna-padevus-ule-ravimiametisse-0> ), we would like to confirm that the email address [email protected] <mailto:[email protected]> can be used to submit safety reports arising from Clinical Investigations with Medical Devices. Thanks in advance for your support. Kind regards, Daiana Daiana Martello Sr Safety & PV Ops Specialist Syneos Health syneoshealth.com <http://www.syneoshealth.com/> <https://www.syneoshealth.com/> Upcoming absence: 17-Apr-2025, 18-Apr-2025, 1-May-2025 EMAIL DISCLAIMER NOTICE: Syneos Health, (the “Company”). This email and any files transmitted may contain information that is privileged, confidential and exempt from disclosure and is intended solely for the intended recipient. If you received this email in error, please inform the sender and delete it. This email neither constitutes an agreement to conduct transactions by electronic means nor creates any legally binding contract or enforceable obligation in the absence of a fully signed written contract. Any views or opinions expressed are solely those of the author and do not necessarily represent those of the Company. Although the Company has taken reasonable precautions to ensure no viruses are present in this email, the Company cannot accept responsibility for any loss or damage arising from the use of this email or attachments.