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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 Currently, the information on the website is short, however, we are planning to upload a comprehensive sponsor guidance document for study submissions in Estonia by the end of February. This document will include all the important details regarding study submission and some frequently asked questions as well. If you are interested, we could share the document with you as soon as it is published. To answer your questions in the e-mail, I will give a short overview of the process in general below. An application for a performance study consists of the following: 1. preparing the documentation, 2. obtaining the opinion of the ethics committee, 2. paying relevant fees, 3. submitting documentation to the State Agency of Medicines. In general, the application form and documentation checklist provided by the MDCG guidance is applicable in Estonia as well. There are some additional documents we require. First, a (positive) ethics committee opinion must be obtained before IVD study submission to the State Agency of Medicines. Second, a copy of an insurance policy ensuring the insurance cover for the compensation for any health damage suffered by a subject must be submitted. The application and documentation can be prepared in Estonian or English language, except the documents used to obtain informed consent of the patient. Informed consent and the accompanying patient information sheet must be prepared in the native language of the subject. Prior to State Agency of Medicines submission, the sponsor must obtain a (positive) opinion of the ethics committee. In Estonia, the CA for medical devices (State Agency of Medicines) and the ethics committees that evaluate clinical investigations and performance studies are separate independent entities. To our knowledge, there are two ethics committees in our field – Research Ethics Committee of the University of Tartu and Research Ethics Committee of the National Institute for Health Development. As they are independent from the State Agency of Medicines, the sponsor shall inquire about their timelines and possible fees directly from the ethical committees. The ethics committee of the State Agency of Medicines does not issue opinions on medical device studies and only does so for medicinal trials. After obtaining the opinion of the ethics committee and to start the process of aquiring a performance study authorisation from the State Agency of Medicines, the sponsor is obliged to pay two kinds of fees: 1. the Statutory Fee (also known as the State fee) of 210 euros, 2. the State Agency of Medicines fee according to the type of study conducted The State fee must be paid before the application to the State Agency of Medicines. No invoice for this payment will be issued. The details for the payment information can be found below. Using the reference number is mandatory on bank transfer. Recipient details Recipient Ministry of Finance Bank details Bank Account number BIC/SWIFT SEB Bank EE891010220034796011 EEUHEE2X Swedbank EE932200221023778606 HABAEE2X LHV Bank EE777700771003813400 LHVBEE22 Luminor Bank EE701700017001577198 NDEAEE2X Transaction information Reference number 2900083031 The State Agency of Medicines fee amount depends on the nature of the performance study (405 or 1457 euros). § 4. Fees for professional assessment of applications for performance studies (1) Regulation (EU) 2017/746 of the European Parliament and of the Council on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU in the case of the performance study referred to in Article 66 (7) point a, if the surgically invasive sampling takes place as part of the performance study and the sampling does not involve a significant risk for the study participants, the fee for the professional evaluation of the application is 405 euros. (2) In the case of the performance study referred to in Article 66 (7) point b of Regulation (EU) 2017/746 of the European Parliament and of the Council, the fee for the professional evaluation of the application is 1,457 euros, if: 1) clinical performance test results may inform decisions related to patient care or be used to guide treatment or 2) conducting the study involves additional invasive procedures or other risks affecting the performance study participants or 3) carrying out the study includes suitability diagnostic equipment, except for performance studies involving suitability diagnostic equipment, in which case sample residues.” The sponsor must determine the type of fee they need to pay according to the study type.The State Agency of Medicines will issue an invoice for the fee. To issue an invoice for the State Agency of Medicines fee, we will require the following information from the sponsor: * name of the company, * registry code, * legal address and * contact information (e-mail, telephone number and name of contact person), * type of fee the sponsor is applying for. The invoice will be issued to the contact person within 10 days after your request. The invoice must be paid within 40 days since the issue date of the invoice. After obtaining the ethics committee opinion and paying all relevant fees, you are all set to submit the study application to the State Agency of Medicines. The documentation will be submitted via e-mail [email protected] <mailto:[email protected]> . In general, sponsors submit their documents using a .zip files and sometimes send the .zip files even in two or more consecutive e-mails, as there may be restrictions for large file sizes. 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: esmaspäev, 10. veebruar 2025 13:21 Adressaat: RA MSO <[email protected]> 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] <mailto:[email protected]> > Sent: 10 February 2025 7:37 AM To: Emma Brown <[email protected] <mailto:[email protected]> > Cc: RA MSO <[email protected] <mailto:[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 <http://www.ravimiamet.ee> Saatja: Emma Brown <[email protected] <mailto:[email protected]> > Saatmisaeg: kolmapäev, 5. veebruar 2025 13:04 Adressaat: RA MSO <[email protected] <mailto:[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. Thank you kindly for this very useful information. Yes please keep me updated when the guidance is published. Best wishes, Emma ________________________________ From: RA MSO <[email protected]> Sent: 10 February 2025 1:13 PM To: Emma Brown <[email protected]> Cc: RA MSO <[email protected]> Subject: Vs: ICF guidance for combined studies of IMP & IVD Dear Dr. Brown Currently, the information on the website is short, however, we are planning to upload a comprehensive sponsor guidance document for study submissions in Estonia by the end of February. This document will include all the important details regarding study submission and some frequently asked questions as well. If you are interested, we could share the document with you as soon as it is published. To answer your questions in the e-mail, I will give a short overview of the process in general below. An application for a performance study consists of the following: 1. preparing the documentation, 2. obtaining the opinion of the ethics committee, 2. paying relevant fees, 3. submitting documentation to the State Agency of Medicines. In general, the application form and documentation checklist provided by the MDCG guidance is applicable in Estonia as well. There are some additional documents we require. First, a (positive) ethics committee opinion must be obtained before IVD study submission to the State Agency of Medicines. Second, a copy of an insurance policy ensuring the insurance cover for the compensation for any health damage suffered by a subject must be submitted. The application and documentation can be prepared in Estonian or English language, except the documents used to obtain informed consent of the patient. Informed consent and the accompanying patient information sheet must be prepared in the native language of the subject. Prior to State Agency of Medicines submission, the sponsor must obtain a (positive) opinion of the ethics committee. In Estonia, the CA for medical devices (State Agency of Medicines) and the ethics committees that evaluate clinical investigations and performance studies are separate independent entities. To our knowledge, there are two ethics committees in our field – Research Ethics Committee of the University of Tartu and Research Ethics Committee of the National Institute for Health Development. As they are independent from the State Agency of Medicines, the sponsor shall inquire about their timelines and possible fees directly from the ethical committees. The ethics committee of the State Agency of Medicines does not issue opinions on medical device studies and only does so for medicinal trials. After obtaining the opinion of the ethics committee and to start the process of aquiring a performance study authorisation from the State Agency of Medicines, the sponsor is obliged to pay two kinds of fees: 1. the Statutory Fee (also known as the State fee) of 210 euros, 2. the State Agency of Medicines fee according to the type of study conducted The State fee must be paid before the application to the State Agency of Medicines. No invoice for this payment will be issued. The details for the payment information can be found below. Using the reference number is mandatory on bank transfer. Recipient details Recipient Ministry of Finance Bank details Bank Account number BIC/SWIFT SEB Bank EE891010220034796011 EEUHEE2X Swedbank EE932200221023778606 HABAEE2X LHV Bank EE777700771003813400 LHVBEE22 Luminor Bank EE701700017001577198 NDEAEE2X Transaction information Reference number 2900083031 The State Agency of Medicines fee amount depends on the nature of the performance study (405 or 1457 euros). § 4. Fees for professional assessment of applications for performance studies (1) Regulation (EU) 2017/746 of the European Parliament and of the Council on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU in the case of the performance study referred to in Article 66 (7) point a, if the surgically invasive sampling takes place as part of the performance study and the sampling does not involve a significant risk for the study participants, the fee for the professional evaluation of the application is 405 euros. (2) In the case of the performance study referred to in Article 66 (7) point b of Regulation (EU) 2017/746 of the European Parliament and of the Council, the fee for the professional evaluation of the application is 1,457 euros, if: 1) clinical performance test results may inform decisions related to patient care or be used to guide treatment or 2) conducting the study involves additional invasive procedures or other risks affecting the performance study participants or 3) carrying out the study includes suitability diagnostic equipment, except for performance studies involving suitability diagnostic equipment, in which case sample residues.” The sponsor must determine the type of fee they need to pay according to the study type.The State Agency of Medicines will issue an invoice for the fee. To issue an invoice for the State Agency of Medicines fee, we will require the following information from the sponsor: * name of the company, * registry code, * legal address and * contact information (e-mail, telephone number and name of contact person), * type of fee the sponsor is applying for. The invoice will be issued to the contact person within 10 days after your request. The invoice must be paid within 40 days since the issue date of the invoice. After obtaining the ethics committee opinion and paying all relevant fees, you are all set to submit the study application to the State Agency of Medicines. The documentation will be submitted via e-mail [email protected] <mailto:[email protected]> . In general, sponsors submit their documents using a .zip files and sometimes send the .zip files even in two or more consecutive e-mails, as there may be restrictions for large file sizes. 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: esmaspäev, 10. veebruar 2025 13:21 Adressaat: RA MSO <[email protected]> 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] <mailto:[email protected]> > Sent: 10 February 2025 7:37 AM To: Emma Brown <[email protected] <mailto:[email protected]> > Cc: RA MSO <[email protected] <mailto:[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 <http://www.ravimiamet.ee> Saatja: Emma Brown <[email protected] <mailto:[email protected]> > Saatmisaeg: kolmapäev, 5. veebruar 2025 13:04 Adressaat: RA MSO <[email protected] <mailto:[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.