Kiri

Dear Merili,

Thank you for your response.

I have one more question regarding our upcoming submission of IVD, CDx medical device. Do you accept combined ICF (one for MD study and pharma trial)? If so, are there any strict requirements to follow? E.g. lisiting names of both studies?

I would appreciate your feedback on this matter.

Kind regards,

Amira

Dear Dr. Podolak,

It is mandatory to include:

a. instructions for use as per Annex XIII  point 2.2 and point 2.3.2 (i) of the Regulation (EU) 2017/746,

b. labels as per Annex XIII point 2.2.

c. CRF - the IVDR does not specify such thing as a case report form. Please include documents as you see fit to provide enough grounds for the Health Board’s assessment

Regarding the clinical trial protocol/synopsis, the Health Board considers the clinical trial protocol/synopsis a highly relevant to performance studies with companion diagnostics devices. Relevant information about the clinical trial should be included in the dossier.

In case of any further questions, please do not hesitate to contact us again.

All the best

Dear Merili,

Thank you for your response.

I would appreciate if you could answer a few more questions:

1. Is it mandatory to include:

1. IFU

2. Labels

3. CRF

In the submission package?

2. As it is a study combined with the pharma trial is it mandatory to include the pharma protocol and / or synopsis in the submission package for the device study?

I would appreciate your support in this matter.

KR,

Amira

Dear Dr. Podolak,

Thank You for Your enquiry. Our answers to Your questions are provided in blue colour:

1. How the submission should be performed? Via email to [email protected]?

Yes, the dossier for a performance study is generally submitted via e-mail to [email protected]

2. How should we proceed with the payment? Additionally, could you please confirm the following fees:

- professional evaluation: 1457 EUR for studies involving CDx, except for the performance studies involving CDx where only residues of samples are used

- expert opinion: 200 EUR/h – invoiced within 10 days from the receipt of expert opinion.

The sponsor is obliged to pay two kinds of fees:
1. The State Fee of 210 euros,

2. the Health Board fee according to the type of study conducted.

According to the State Fees Act § 298¹ (2), a state fee of 210 euros is paid for the review of an application for conducting performance evaluation of an in vitro diagnostic medical device. The payment must be made before the application submission to the Health Board. No invoice for this payment will be issued. The details on the payment information is found below:

¹ NB! The reference number is mandatory on bank transfer!

In addition to the State fee, the sposnor is obliged to pay the fee to the Health Board for professional assessment of the performance study before the submission of an application for the performance study. The Health Board fee is established in the regulation of the minister in charge of the policy sector. For the study You described in Your initial e-mail, the fee would be 1457 EUR as per § 4 (2) of the aforementioned regulation.

  (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.”

We will issue an invoice for the Health Board fee stated above. To issue an invoice for the Health Board fees, we will require the following information:

• 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

3. What are the timelines to validate the submission, review the study and give decision? Also, what are the timelines for the Sponsor in case of comments?

The application reviewing procedure conducted by the Health Board is thoroughly described in the Article 66 of Regulation (EU) 2017/746

4. Besides the ICF, are there any other documents required in Estonian? Additionally, is the ICF required in Russian as well?

In case You do not foresee any participants with Russian as their native language, Russian ICF will be considered not mandatory. However, if there are any participants with Russian as their native language (which is likely), ICF must be obtained in Russian language. This is regulated in Medical Devices Act § 21¹. (6):

 (6) Where the documents specified in Annex XV of Regulation (EU) 2017/745 or in Annex XIII of Regulation (EU) 2017/746 of the European Parliament and of the Council must be submitted, these may be drawn either in Estonian or English, except for the documents used for obtaining the informed consent which must be drawn in the native language of the participant in the investigation.

5. Are there any additional considerations to take into account for the application for a study combined with a pharmaceutical trial?

Please note that for the pharmaceutical trial, authorisation from the Estonian Medicines Agency is required, however, it is not mandatory to obtain the authorisation before submitting the study to the Health Board.

Please be aware that before any documents for the study are submitted to the Health Board, an opinion of the ethics committe must be obtained. Health Board will consider Your application for the performance study incomplete without the opinion of the ethics committee. 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 competent authority, please inquire about their timelines and possible fees and required documents directly from them.

Best regards,

Dear members of Health Board,

I would like to contact you from the IQVIA MedTech CRO, as an authorized Clinical Performance Study (CPS) applicant for the Sponsor. We plan to submit to your assessment an initial request for authorization of an interventional CPS with a CE-marked IVD Companion Diagnostic (regulatory pathway in accordance with IVDR Art. 58.1). Please note that CPS will be submitted as a part of combined study with a pharmaceutical trial; however, IQVIA MedTech will only be responsible for the submission of the device study.

I would like to ask you about the submission requirements:

1. How the submission should be performed? Via email to [email protected]?

2. How should we proceed with the payment? Additionally, could you please confirm the following fees:

• professional evaluation: 1457 EUR for studies involving CDx, except for the performance studies involving CDx where only residues of samples are used   , 

• expert opinion: 200 EUR/h – invoiced within 10 days from the receipt of expert opinion.

3. What are the timelines to validate the submission, review the study and give the decision? Also, what are the timelines for the Sponsor in case of comments?

4. Besides the ICF, are there any other documents required in Estonian? Addtionally, is the ICF required in Russian as well?

5. Are there any additional considerations to take into account for the application for a study combined with a pharmaceutical trial?

I would appreciate your prompt response to my email at your earliest convenience.

Kind regards,

Amira Podolak, Ph.D.

Sr. Regulatory & Start-Up Specialist

IQVIA MedTech, Clinical Operations

Learn more about IQVIA MedTech

Home Based (Gdynia, Poland)

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