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Saatja: RA MSO </O=SOTSIAALMINISTEERIUM/OU=EXCHANGE ADMINISTRATIVE GROUP (FYDIBOHF23SPDLT)/CN=RECIPIENTS/CN=72F3C63240224E00B8EFA069E66B5C58-RA> Saaja: Mihaela Bicanic, ivireg, RA MSO Teema: Vs: PV Requirements - Estonia Medical Devices Clinical trial Dear Michaela, Thank You for Your inquiry. SAE reports in Estonia are submitted via our email [email protected] <mailto:[email protected]> . Please do not use the EMDDB to submit SAE reports. In general, Estonian Medical Devices Act <https://www.riigiteataja.ee/en/eli/ee/510012025003/consolide/current> does not specify any safety reporting requirements. All safety reporting should be prepared in accordance with the Regulation (EU) 2017/745 (MDR) and following the guidance MDCG 2020-10/1 <https://health.ec.europa.eu/document/download/0537d335-7eed-4087-b65d-3c2bd8c72c1a_en?filename=md_mdcg_2020-10-1_guidance_safety_reporting_en.pdf> . Information about reporting forms, timelines and requirements are found in these documents. Translation to Estonian language is not required for safety reporting regarding clinical investigations. In case of any further concerns, please do not hesitate to contact us again. 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: Mihaela Bicanic <[email protected]> Saatmisaeg: neljapäev, 13. märts 2025 15:13 Adressaat: RA MSO <[email protected]> Koopia: ivireg <[email protected]> Teema: PV Requirements - Estonia Medical Devices Clinical trial Tähelepanu! Tegemist on väljastpoolt asutust saabunud kirjaga. Tundmatu saatja korral palume linke ja faile mitte avada. Dear Ms./Mrs., I hope this email finds you well. I am reaching out to seek clarification on the reporting obligations for Medical devices in clinical trial Estonia follows EU Regulation 2017/745, along with the guidelines set forth by the Medical Devices Coordination Group (MDCG), specifically MDCG 2020-10/1 rev.1 on safety reporting in clinical investigations and its Appendix: Clinical Investigation Summary Safety Report Form. Additionally, the national Medical Devices Act applies From our understanding adverse incidents are submitted through the Estonian Medical Devices Appliances Database (EMDDB). In the EMDDB <https://msa.sm.ee/eng> website, the information about reporting adverse incidents is limited. I would like to ask for your support in clarifying the following: 1. Could you please confirm that the MDCG 2020-10/1 rev 1 Appendix: SAE report form is to be submitted through EMDDB? 2. Are there any specific requirements for the SAE report form, such as preferred language or whether a signature is needed? 3. ‘’Forms’’ section of EMDDB <https://msa.sm.ee/eng/form/> provides a user guide for the database. Is there a similar guide available that explains the process of reporting adverse incidents through the system? 4. If technical issues arise, is there an alternative method for submitting adverse incident reports? We would greatly appreciate your guidance on these matters. Please let us know if any further details are required. Looking forward to your response. Best regards, Mihaela Bicanic iVigee <http://www.ivigee.com/> Senior PV Intelligence Manager [email protected] <mailto:[email protected]> Watch iViReg in Action <https://share.vidyard.com/watch/6my4C2Mg7S2TWEBaQ1qJEo?> | Real-Time PV Intelligence for 100+ Countries Your Perspective Matters - Let Us Know How We’re Doing <https://share.hsforms.com/1M01Ml6x-SXqUr-ZAjtloSwc4w93> . The content of this message and any attachments to it are confidential. If you have received it by mistake, please inform us and then delete it from your systems. Any review, dissemination, distribution, or duplication of this communication is strictly prohibited. The integrity and security of this email cannot be guaranteed over the internet, therefore, the sender will not be held liable for any damage caused by the message. Also, please note that this message expresses discussions to date, is purely informative and does not legally bind the sender, whatsoever. Saatja: Mihaela Bicanic <[email protected]> Saaja: RA MSO, ivireg, RA MSO Teema: Re: PV Requirements - Estonia Medical Devices Clinical trial Tähelepanu! Tegemist on väljastpoolt asutust saabunud kirjaga. Tundmatu saatja korral palume linke ja faile mitte avada. Dear Merili, Thank you very much for your prompt response. At this time, I don’t have any further questions, if anything else will arise I will contact you. Kind regards, Mihaela Mihaela Bicanic iVigee <http://www.ivigee.com/> Senior PV Intelligence Manager [email protected] <mailto:[email protected]> Watch iViReg in Action <https://share.vidyard.com/watch/6my4C2Mg7S2TWEBaQ1qJEo?> | Real-Time PV Intelligence for 100+ Countries Your Perspective Matters - Let Us Know How We’re Doing <https://share.hsforms.com/1M01Ml6x-SXqUr-ZAjtloSwc4w93> . The content of this message and any attachments to it are confidential. If you have received it by mistake, please inform us and then delete it from your systems. Any review, dissemination, distribution, or duplication of this communication is strictly prohibited. The integrity and security of this email cannot be guaranteed over the internet, therefore, the sender will not be held liable for any damage caused by the message. Also, please note that this message expresses discussions to date, is purely informative and does not legally bind the sender, whatsoever. From: RA MSO <[email protected]> Date: Sunday, 16 March 2025 at 18:02 To: Mihaela Bicanic <[email protected]> Cc: ivireg <[email protected]>, RA MSO <[email protected]> Subject: Vs: PV Requirements - Estonia Medical Devices Clinical trial You don't often get email from [email protected]. Learn why this is important <https://aka.ms/LearnAboutSenderIdentification> Dear Michaela, Thank You for Your inquiry. SAE reports in Estonia are submitted via our email [email protected] <mailto:[email protected]> . Please do not use the EMDDB to submit SAE reports. In general, Estonian Medical Devices Act <https://www.riigiteataja.ee/en/eli/ee/510012025003/consolide/current> does not specify any safety reporting requirements. All safety reporting should be prepared in accordance with the Regulation (EU) 2017/745 (MDR) and following the guidance MDCG 2020-10/1 <https://health.ec.europa.eu/document/download/0537d335-7eed-4087-b65d-3c2bd8c72c1a_en?filename=md_mdcg_2020-10-1_guidance_safety_reporting_en.pdf> . Information about reporting forms, timelines and requirements are found in these documents. Translation to Estonian language is not required for safety reporting regarding clinical investigations. In case of any further concerns, please do not hesitate to contact us again. 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: Mihaela Bicanic <[email protected]> Saatmisaeg: neljapäev, 13. märts 2025 15:13 Adressaat: RA MSO <[email protected]> Koopia: ivireg <[email protected]> Teema: PV Requirements - Estonia Medical Devices Clinical trial Tähelepanu! Tegemist on väljastpoolt asutust saabunud kirjaga. Tundmatu saatja korral palume linke ja faile mitte avada. Dear Ms./Mrs., I hope this email finds you well. I am reaching out to seek clarification on the reporting obligations for Medical devices in clinical trial Estonia follows EU Regulation 2017/745, along with the guidelines set forth by the Medical Devices Coordination Group (MDCG), specifically MDCG 2020-10/1 rev.1 on safety reporting in clinical investigations and its Appendix: Clinical Investigation Summary Safety Report Form. Additionally, the national Medical Devices Act applies From our understanding adverse incidents are submitted through the Estonian Medical Devices Appliances Database (EMDDB). In the EMDDB <https://msa.sm.ee/eng> website, the information about reporting adverse incidents is limited. I would like to ask for your support in clarifying the following: 1. Could you please confirm that the MDCG 2020-10/1 rev 1 Appendix: SAE report form is to be submitted through EMDDB? 2. Are there any specific requirements for the SAE report form, such as preferred language or whether a signature is needed? 3. ‘’Forms’’ section of EMDDB <https://msa.sm.ee/eng/form/> provides a user guide for the database. Is there a similar guide available that explains the process of reporting adverse incidents through the system? 4. If technical issues arise, is there an alternative method for submitting adverse incident reports? We would greatly appreciate your guidance on these matters. Please let us know if any further details are required. Looking forward to your response. Best regards, Mihaela Bicanic iVigee <http://www.ivigee.com/> Senior PV Intelligence Manager [email protected] <mailto:[email protected]> Watch iViReg in Action <https://share.vidyard.com/watch/6my4C2Mg7S2TWEBaQ1qJEo?> | Real-Time PV Intelligence for 100+ Countries Your Perspective Matters - Let Us Know How We’re Doing <https://share.hsforms.com/1M01Ml6x-SXqUr-ZAjtloSwc4w93> . The content of this message and any attachments to it are confidential. If you have received it by mistake, please inform us and then delete it from your systems. Any review, dissemination, distribution, or duplication of this communication is strictly prohibited. The integrity and security of this email cannot be guaranteed over the internet, therefore, the sender will not be held liable for any damage caused by the message. Also, please note that this message expresses discussions to date, is purely informative and does not legally bind the sender, whatsoever.