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The Estonian State Agency of Medicines Takes Over Responsibility for Medical Devices in Estonia

02.12.2024 | 14:00

The administrative responsibilities of the Estonian Health Board related to the area of medical devices will be transferred to the Estonian State Agency of Medicines from 1st of January 2025.

Katrin Kiisk, Director General of the Estonian State Agency of Medicines, has noted that the foundational principles ensuring the safety of medicines and medical devices are both fundamentally similar. These principles cover the entire product lifecycle, which includes development, market authorization, supervision, safety monitoring, product recalls and the classification of products as either a medicine or a medical device. This alignment is also why the oversight of medical devices is managed by medicine agencies across the European Union.

The Estonian State Agency of Medicines has established a strong reputation for conducting international scientific evaluations, engaging in EU-wide supervisory processes, and upholding a quality system that guarantees consistent service provision throughout Estonia.

In the context of this transition, the personnel currently responsible for medical devices at the Estonian Health Board will be transferring to the Medicines Agency.

Additionally, starting from 01.01.2025, the general email address for the former Medical Devices Department ([email protected]) will be replaced by [email protected].

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