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.
The personnel currently responsible for the medical devices sector at the Health Board will also transfer to the State Agency of Medicines along with their duties. Starting from 01.01.2025, the current general email address of the Medical Devices Department ([email protected]) will be replaced by [email protected].
Details of the changes and the explanatory memorandum are available on the website of the State Agency of Medicines.
