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Saatja: Emma Brown <[email protected]> Saaja: RA MSO Teema: ICF guidance for combined studies of IMP & IVD Tähelepanu! Tegemist on väljastpoolt asutust saabunud kirjaga. Tundmatu saatja korral palume linke ja faile mitte avada. Dear Sir, Dear Madam, Please forgive the unsolicited email. I am trying to compile information for different countries under IVDR on the requirements for ICF when the study is combined IMP and IVD. To date – my experience is that different countries have different requirements for the ICF: •     Joint ICF for IVD and IMP •     Separate ICF for IVD and IMP In order to reduce the burden of RFIs and the workload to both Ethics Committees and the Sponsor submitting the application under IVDR/CTR I’m collating the ICF requirements. Please can you advise what is the position for Estonia on ICFs for combined studies? Many thanks and best wishes, Dr Emma Brown Dr Emma Brown The Bradfield Centre 184 Cambridge Science Park, Milton Road Cambridgeshire, CB4 0GA NOTICE: This message, including any attachments, is intended for the use of the party to which it is addressed and may contain information that is privileged, confidential, and exempt from disclosure. If you are not the intended recipient, any dissemination, distribution, or copying of this communication is strictly prohibited. If you have received this communication in error, please contact the sender immediately by replying to this e-mail and delete the original and any copies of this message. It is the recipient's sole responsibility to ensure that this message and any attachments are virus-free. Saatja: Emma Brown <[email protected]> Saaja: RA MSO Teema: Re: ICF guidance for combined studies of IMP & IVD Tähelepanu! Tegemist on väljastpoolt asutust saabunud kirjaga. Tundmatu saatja korral palume linke ja faile mitte avada. Dear Merili Saar-Abroi, Apologies for another email. When I visited the www.ravimiamet.ee <http://www.ravimiamet.ee> website to review the document requirements and submission process I see there is a request to email for this information. Please can you direct me to the information required for submission (or confirm that the MDCG application form and list of supporting documents is acceptable) and details for how the submission is made (e.g. Email with documents as .zip folder or other). I note that ethical committee approval is required before making the application to yourselves as well as participant insurance cover. If there are any other specific country requirements that differ from the rest of EU legislation, please also could you share these? Many thanks and best wishes, Emma ________________________________ From: RA MSO <[email protected]> Sent: 10 February 2025 7:37 AM To: Emma Brown <[email protected]> Cc: RA MSO <[email protected]> Subject: Vs: ICF guidance for combined studies of IMP & IVD Dear Dr. Brown, Thank You for Your enquiry. In Estonia, we accept both the joint and separate ICF. However, we have had issues with joint ICF-s as study sponsors tend to focus heavily on the medicinal trial while leaving out imporant details about the device study in a joint ICF. In case we find that the ICF and the patient information sheet does not emphasize the device study enough and we are hesitant about whether the patient is able to understand that they are included in not one, but two studies, we will require updates to the ICF, which will then lead to substantial modifications of the medicinal trial, new ethics committee approvals etc. We recommend to prepare separate ICF-s as this would ease the sponsors burden in case any updates are necessary for the ICF. With separate ICF-s, the sponsor does not have to submit the document again to medicinal trial CA and the ethics committee in case the medicinal trial has already received a CA approval and a positive ethics committee opinion in case we require updates in the IVD study-s ICF. Additionally, this will ensure that the patient understands that they are included in two separate studies – a medicinal trial and an IVD performance study. In case of any further questions, 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: Emma Brown <[email protected]> Saatmisaeg: kolmapäev, 5. veebruar 2025 13:04 Adressaat: RA MSO <[email protected]> Teema: ICF guidance for combined studies of IMP & IVD Tähelepanu! Tegemist on väljastpoolt asutust saabunud kirjaga. Tundmatu saatja korral palume linke ja faile mitte avada. Dear Sir, Dear Madam, Please forgive the unsolicited email. I am trying to compile information for different countries under IVDR on the requirements for ICF when the study is combined IMP and IVD. To date – my experience is that different countries have different requirements for the ICF: •     Joint ICF for IVD and IMP •     Separate ICF for IVD and IMP In order to reduce the burden of RFIs and the workload to both Ethics Committees and the Sponsor submitting the application under IVDR/CTR I’m collating the ICF requirements. Please can you advise what is the position for Estonia on ICFs for combined studies? Many thanks and best wishes, Dr Emma Brown Dr Emma Brown The Bradfield Centre 184 Cambridge Science Park, Milton Road Cambridgeshire, CB4 0GA NOTICE: This message, including any attachments, is intended for the use of the party to which it is addressed and may contain information that is privileged, confidential, and exempt from disclosure. If you are not the intended recipient, any dissemination, distribution, or copying of this communication is strictly prohibited. If you have received this communication in error, please contact the sender immediately by replying to this e-mail and delete the original and any copies of this message. It is the recipient's sole responsibility to ensure that this message and any attachments are virus-free. Saatja: RA MSO </o=Sotsiaalministeerium/ou=Exchange Administrative Group (FYDIBOHF23SPDLT)/cn=Recipients/cn=72f3c63240224e00b8efa069e66b5c58-RA> Saaja: 'Emma Brown', RA MSO Teema: Vs: ICF guidance for combined studies of IMP & IVD Dear Dr. Brown, Thank You for Your enquiry. In Estonia, we accept both the joint and separate ICF. However, we have had issues with joint ICF-s as study sponsors tend to focus heavily on the medicinal trial while leaving out imporant details about the device study in a joint ICF. In case we find that the ICF and the patient information sheet does not emphasize the device study enough and we are hesitant about whether the patient is able to understand that they are included in not one, but two studies, we will require updates to the ICF, which will then lead to substantial modifications of the medicinal trial, new ethics committee approvals etc. We recommend to prepare separate ICF-s as this would ease the sponsors burden in case any updates are necessary for the ICF. With separate ICF-s, the sponsor does not have to submit the document again to medicinal trial CA and the ethics committee in case the medicinal trial has already received a CA approval and a positive ethics committee opinion in case we require updates in the IVD study-s ICF. Additionally, this will ensure that the patient understands that they are included in two separate studies – a medicinal trial and an IVD performance study. In case of any further questions, 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: Emma Brown <[email protected]> Saatmisaeg: kolmapäev, 5. veebruar 2025 13:04 Adressaat: RA MSO <[email protected]> Teema: ICF guidance for combined studies of IMP & IVD Tähelepanu! Tegemist on väljastpoolt asutust saabunud kirjaga. Tundmatu saatja korral palume linke ja faile mitte avada. Dear Sir, Dear Madam, Please forgive the unsolicited email. I am trying to compile information for different countries under IVDR on the requirements for ICF when the study is combined IMP and IVD. To date – my experience is that different countries have different requirements for the ICF: •     Joint ICF for IVD and IMP •     Separate ICF for IVD and IMP In order to reduce the burden of RFIs and the workload to both Ethics Committees and the Sponsor submitting the application under IVDR/CTR I’m collating the ICF requirements. Please can you advise what is the position for Estonia on ICFs for combined studies? Many thanks and best wishes, Dr Emma Brown Dr Emma Brown The Bradfield Centre 184 Cambridge Science Park, Milton Road Cambridgeshire, CB4 0GA NOTICE: This message, including any attachments, is intended for the use of the party to which it is addressed and may contain information that is privileged, confidential, and exempt from disclosure. If you are not the intended recipient, any dissemination, distribution, or copying of this communication is strictly prohibited. If you have received this communication in error, please contact the sender immediately by replying to this e-mail and delete the original and any copies of this message. It is the recipient's sole responsibility to ensure that this message and any attachments are virus-free. Saatja: Emma Brown <[email protected]> Saaja: RA MSO Teema: Re: ICF guidance for combined studies of IMP & IVD Tähelepanu! Tegemist on väljastpoolt asutust saabunud kirjaga. Tundmatu saatja korral palume linke ja faile mitte avada. Dear Merili Saar-Abroi, Thank you very much for your detailed and prompt response. I have no further questions and understand your rationale. If there are questions in due course I will reach out. Wishing you a great day. Best wishes, Emma ________________________________ From: RA MSO <[email protected]> Sent: 10 February 2025 7:37 AM To: Emma Brown <[email protected]> Cc: RA MSO <[email protected]> Subject: Vs: ICF guidance for combined studies of IMP & IVD Dear Dr. Brown, Thank You for Your enquiry. In Estonia, we accept both the joint and separate ICF. However, we have had issues with joint ICF-s as study sponsors tend to focus heavily on the medicinal trial while leaving out imporant details about the device study in a joint ICF. In case we find that the ICF and the patient information sheet does not emphasize the device study enough and we are hesitant about whether the patient is able to understand that they are included in not one, but two studies, we will require updates to the ICF, which will then lead to substantial modifications of the medicinal trial, new ethics committee approvals etc. We recommend to prepare separate ICF-s as this would ease the sponsors burden in case any updates are necessary for the ICF. With separate ICF-s, the sponsor does not have to submit the document again to medicinal trial CA and the ethics committee in case the medicinal trial has already received a CA approval and a positive ethics committee opinion in case we require updates in the IVD study-s ICF. Additionally, this will ensure that the patient understands that they are included in two separate studies – a medicinal trial and an IVD performance study. In case of any further questions, 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: Emma Brown <[email protected]> Saatmisaeg: kolmapäev, 5. veebruar 2025 13:04 Adressaat: RA MSO <[email protected]> Teema: ICF guidance for combined studies of IMP & IVD Tähelepanu! Tegemist on väljastpoolt asutust saabunud kirjaga. Tundmatu saatja korral palume linke ja faile mitte avada. Dear Sir, Dear Madam, Please forgive the unsolicited email. I am trying to compile information for different countries under IVDR on the requirements for ICF when the study is combined IMP and IVD. To date – my experience is that different countries have different requirements for the ICF: •     Joint ICF for IVD and IMP •     Separate ICF for IVD and IMP In order to reduce the burden of RFIs and the workload to both Ethics Committees and the Sponsor submitting the application under IVDR/CTR I’m collating the ICF requirements. Please can you advise what is the position for Estonia on ICFs for combined studies? Many thanks and best wishes, Dr Emma Brown Dr Emma Brown The Bradfield Centre 184 Cambridge Science Park, Milton Road Cambridgeshire, CB4 0GA NOTICE: This message, including any attachments, is intended for the use of the party to which it is addressed and may contain information that is privileged, confidential, and exempt from disclosure. If you are not the intended recipient, any dissemination, distribution, or copying of this communication is strictly prohibited. If you have received this communication in error, please contact the sender immediately by replying to this e-mail and delete the original and any copies of this message. It is the recipient's sole responsibility to ensure that this message and any attachments are virus-free.