Vastuskiri

Dear Dr. Podolak

According to the IVDR article 66, we are required to notify the sponsor as to whether the performance study falls within the scope of the IVDR and as to whether the application dossier is complete within 10 days of receiving the application. In case you apply December 17th at the latest, we will validate the application or ask for additional comments regarding your application December 27th at the latest. In 2025, we will be available again starting from January 6th. As we are transferring to the State Agency of Medicines starting from January 1st, 2025, our e-mail address from then on will be [email protected]

All of the medical devices department and it’s employees will be transferred from the Health Board to the State Agency of Medicines in full, therefore, the application will be transferred to the State Agency of Medicine automatically. No adjustments from the sponsor regarding our transfer are foreseen.

All fees remain valid and will be transferred internally from the Health Board and the State Agency of Medicines. The sponsor will not have any obligations regarding the fees already paid.

All the best,

Dear Sirs,

I would like to ask if there is any break planned for the Christmas period. If we apply before Christmas, is it likely that we will receive validation comments by the end of this year?

In addition, I would like to make sure how the evaluation of applications will look like due to the change in the authority for medical device testing? Will applications submitted in December still be evaluated by the Health Board, or will they be transferred to the State Agency of Medicines with the new year?

I would also like to ask if we do not manage to submit the application in December and have to submit it to the State Agency of Medicines in January, does the fee we have already submitted remain valid? Would we have to start some kind of procedure to redirect the funds or refund and make the payment again to the new competent authority?

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