Navigating Medical Device Compliance in Estonia: Insights from the Health Board
Medical Devices Department, Estonian Health Board
The Health Board is responsible for medical qualification recognition, device regulation, disease surveillance, risk analysis, cosmetic products, chemical safety, and drinking water. Their mission is to promote public health and a healthy living environment. Their vision is to make Estonians aware of health-promoting living environments by 2025, through collaboration between the Health Board, people, and various parties.
Class I, IIa, IIb, III
The registration process takes about 4-6 weeks after submission for Class I devices. For the other classes, it depends on the contract with the notified body and the type of device.
No Fees
5 Years
The information on medical devices in Estonia must be presented in Estonian, with translations ensured by the distributor or marketer.
The two European Regulations on medical devices, MDR and IVDR, replaced Directives MDD and AIMDD in 2017. While initially having transitional periods, both regulations now fully apply in Estonia: MDR since May 2020 and IVDR since May 2022. Consequently, all medical devices marketed or used in Estonia must comply with the relevant regulation, and all classes of devices require notification to the Estonian Health Board.
Estonia has limited local production of medical devices, with a significant reliance on imports to meet healthcare needs. Approximately 80% of the medical devices utilized in the country are sourced from prominent international markets, including the United States, Japan, Germany, and Mexico. The demand for medical devices in Estonia is particularly high in critical areas such as cardiovascular and surgical equipment, as well as diagnostic devices.
The nation’s preference for importing medical devices underscores a reliance on technologically advanced and globally recognized manufacturers. The United States, Japan, Germany, and Mexico are pivotal contributors to Estonia’s healthcare infrastructure, providing a diverse range of essential medical equipment. The emphasis on imports indicates the country’s commitment to accessing cutting-edge technologies and high-quality medical solutions from leading global suppliers.
The prominence of cardio and surgical equipment, along with diagnostic devices, in Estonia’s medical device landscape highlights the significance of advanced healthcare technologies in addressing critical health challenges. The reliance on international markets not only underscores Estonia’s commitment to ensuring quality healthcare but also reflects the interconnected nature of the global medical device industry in meeting the diverse and evolving healthcare needs of the country.
Before placing a medical device into the market.
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Our team will be happy to respond your queries. Contact us directly with your questions or for scheduling FREE consultation and we’ll be in touch as soon as possible.
Our team will be happy to respond your queries. Contact us directly with your questions or for scheduling FREE consultation and we’ll be in touch as soon as possible.
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