Vastuskiri

Dear Ashwina Seerutun,

Below I will try to answer question by question:

1. Application Requirements: What are the necessary documents and information needed for the submission of companion diagnostics' application in Estonia? Are there specific guidelines or templates available for preparing the application? And the fees to process the application.

As Regulation (EU) 2017/746 is fully applicable, all the relevant provisions of this legal act have to be followed. MDCG 2022-19 Guidance includes list of application/notification documents for performance studies.

Detailed information about national requirements and fees is given in national regulation Medical Devices Act and on Health Board web site - https://terviseamet.ee/en/clinical-investigations-and-performance-studies

Shortly, before submitting the application to Competent Authority two kind of fees have to be paid – State Fee 210€ for the review of an application and fee for professional assessment of application, which is payable directly to Health Board and depends on type of study. For more details please refer to relevant national regulation § 4. Unfortunately it is available only in Estonian, but please use some machine translation feature. Please contact [email protected] before submitting your application to request an invoice.

2. Performance Studies Notification: What are the guidelines for notifying relevant authorities about the initiation of performance studies for companion diagnostics in Estonia ? Are there specific timelines or deadlines for notifying authorities, and how is this process conducted?

Please refer to previous answer, especially information given on Health Board website. Additionally, please see Medical Devices Act § 21¹.

3. Regulatory Pathway: Could you provide an overview of the regulatory pathway for companion diagnostics in Estonia, including any applicable laws or regulations? Is there a specific regulatory body responsible for overseeing companion diagnostics' approvals and performance studies?

Provisions of Regulation (EU) 2017/746 apply, as well as national provisions. Please see previously linked Medical Devices Act § 21¹ – 22¹ and information on Health Board website.

4. Acceptance Criteria: What are the key criteria that authorities consider when evaluating applications for companion diagnostics' approval and performance studies? Are there any specific safety or efficacy thresholds that need to be met?

No specific criteria besides given in relevant legal acts and possibly applying standards.

5. How and To which competent authority are Serious Adverse Incidents and Other Incidents Reported? What are the timelines for reporting SAEs?

Reporting criteria of adverse events are considered in IVDR Article 76. Additionally, Guidance MDCG 2020-10 may be helpful. Though it is  considering safety reporting under MDR 2017/745, general principles are the same for IVD-s as well, including agreed reporting lines and timelines (Sections 7-8) .

6. Contact Information: Please provide the contact details of the relevant department or personnel we can liaise with for further inquiries or clarifications.

For all queries please always contact us via general e-mail of Medical Devices Department [email protected]

7. What are the costs involved for application and Notification to Competent Authority?

Please see information on Health Board web site (previously linked).

8. What are the timelines for Ethics Approval?

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 evaluating medical devices studies  – Research Ethics Committee of the University of Tartu and Research Ethics Committee of the National Institute for Health Development.  For timelines and fees please contact them directly.

I would be grateful if you could provide a list of requirements for

• Authorization  and Notification of companion diagnostic under the IVDR to competent authority in Bulgaria

• Application to Competent Authority in Estonia

• The applicable fee for Notification and Application

• The SAE reporting timelines.

We believe that information above already provides needed information (excluding any specifics on Bulgaria). In case of additional specific questions you can always contact us again.

Best regards,

Sofia Ratušnaja

Chief Specialist 

Medical Devices Department

+372 5661 5491

[email protected] | [email protected] 

Republic of Estonia

Health Board

+372 794 3500

[email protected] 

www.terviseamet.ee

Paldiski mnt 81, 10614 Tallinn

Estonia

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Dear Sir/ madame 

To gain a comprehensive understanding of the application process and notification requirements for performance studies related to companion diagnostics, we kindly request your assistance in providing us with the following information:

1. Application Requirements: What are the necessary documents and information needed for the submission of companion diagnostics' application in Estonia? Are there specific guidelines or templates available for preparing the application? And the fees to process the application.

2. Performance Studies Notification: What are the guidelines for notifying relevant authorities about the initiation of performance studies for companion diagnostics in Estonia ? Are there specific timelines or deadlines for notifying authorities, and how is this process conducted?

3. Regulatory Pathway: Could you provide an overview of the regulatory pathway for companion diagnostics in Estonia, including any applicable laws or regulations? Is there a specific regulatory body responsible for overseeing companion diagnostics' approvals and performance studies?

4. Acceptance Criteria: What are the key criteria that authorities consider when evaluating applications for companion diagnostics' approval and performance studies? Are there any specific safety or efficacy thresholds that need to be met?

5. How and To which competent authority are Serious Adverse Incidents and Other Incidents Reported? What are the timelines for reporting SAEs?

6. Contact Information: Please provide the contact details of the relevant department or personnel we can liaise with for further inquiries or clarifications.

7. What are the costs involved for application and Notification to Competent Authority?

8. What are the timelines for Ethics Approval?

I would be grateful if you could provide a list of requirements for

• Authorization  and Notification of companion diagnostic under the IVDR to competent authority in Bulgaria

• Application to Competent Authority in Estonia

• The applicable fee for Notification and Application

• The SAE reporting timelines.

Ashwina Lutchumun

Clinical Affairs Specialist, Global Clinical affairs Operations

QIAGEN

Sample to Insight

QIAGEN UK (Remote)

[email protected]
www.qiagen.com

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