Vastuskiri

Dear Nerijus,

Thank You for Your inquiry.

An application for a clinical investigation (CI)/performance study (PS) consists of the following:
1. obtaining the opinion of the ethics committee as per Estonian Medical Devices Act § 22 (1),
2. paying all relevant fees,
3. submitting any necessary documentation for the study.

In Estonia, the competent authority for medical devices and the ethics committees that evaluate medical device clinical investigations and in vitro diagnostic medical device performance studies are separate independent entities. These ethics committees are not required by law to notify us about their existence. 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, the sponsor shall inquire about their timelines and possible fees directly from the ethical committees.

After the acquirement of the opinion of the ethics committee and to start the process of  study authorisation by the Health Board, 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, a state fee of 210 euros is paid for the review of an application for a CI/PS. 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 can be found below in Table 1.

Table 1. Payment information for the State Fee.

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

In addition to the State fee, the sponsor 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 § 3 for a CI and § 4 for a PS. The fee can be either 405 euros or 1457 euros depending on the type of the study conducted.

The sponsor must determine the type of fee according to whether the study falls under § 3 (1) or § 3 (2) in case of a CI or under § 4 (1) or § 4 (2) in case of a PS described in the regulation of the minister in charge of the policy sector. 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.

After obtaining the opinion of an ethics committee and paying relevant fees, the sponsor of a CI/PS is required to submit an application to the Health Board via e-mail: mso@terviseamet.ee. The contents of the documents are throughly described in the Regulation (EU) 2017/745 Chapter VI and Annexes XIV and XV regarding a CI and in the Regulation (EU) 2017/746 Chapter VI and Annexes XIII and XIV regarding a PS. The application form and all other relevant documents for conducting a performance study can be found from the Medical Device Coordination Group guidance documents MDCG 2021-08 Clinical Investigation application/notification documents or from MDCG 2022-19 Performance study application/notification documents under Regulation (EU) 2017/746.  All documents may be drawn in either Estonian or English language, except for the documents used for obtaining the informed consent which must be drawn in the native language of the patient participating in the study.

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

All the best,

Dears,

I would appreciate it if you could send me the list of documents (or web link with it) needed for the initial submission of the Medical Device Study for CA approval.

Could you please list what is needed for MDR and IVDR studies?  As well please provide the Application Form and other local forms that must be submitted only in Estonian.

Could you please confirm that the following price is correct:

„A state fee of 576 euros shall be paid for the review of an application for the permit for a clinical investigation of a medical device, and 27 euros shall be paid for each additional research centre“

Thank you in advance for your response.

Kind regards,