Kiri

Dear Sponsor,

We wish to formally inform you that, effective January 1st, 2025, the Estonian Medical Devices Department will transition from the Health Board to the State Agency of Medicines. This reorganization will transfer all employees, resources, and operations previously under the Health Board to the State Agency of Medicines in their entirety.

Please note that this transition will not impose any additional obligations on study sponsors. Moreover, it will have no impact on your ongoing clinical studies. Your initial application, dossier, and all related documentation and data will be automatically transferred to the State Agency of Medicines.

Starting from January 1st, 2025, please direct all correspondence to the following email address: [email protected]. Additionally, all public information regarding the conduct of clinical studies for medical devices and in vitro diagnostic medical devices will be available on our website at ravimiamet.ee.

We remain committed to supporting your studies and ensuring a smooth transition during this organizational change. Should you have any questions or require further clarification, please do not hesitate to contact us.

All the best,

Merili Saar-Abroi

Chief Specialist

Department of Medical Devices

Phone +372 554 3041

[email protected]  | [email protected]

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