Estonia Medical Device Registration

Navigating Medical Device Compliance in Estonia: Insights from the Health Board

Regulatory Authority

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.

Link for Regulatory Authority

https://www.terviseamet.ee/en/medical-devices/regulatory-controls#:~:text=A%20medical%20device%20placed%20on,diagnostic%20medical%20devices%20is%20also

Local Regulation

• Estonian Medical Devices Act (13 Oct. 2004)
• Medical Device Regulation (EU) 2017/745

Classification of Medical Devices

Class I, IIa, IIb, III

Listing or Registration Requirements

• Obligatory for Class IIa, IIb, III, and active implantable medical devices and recommended for Class I devices and IVDs to market their devices in Estonia, manufacturers must apply for a CE marking for each of the devices they intend to market. A CE marking is a sign of conformity with European Union medical device regulations and allows the device to be freely marketed anywhere within the EU member states. A device doesn’t necessarily have to be registered in Estonia to be marketed in the country; it can be registered in any other EU member state to be authorized for sale in Estonia.
• Medical device registration in the EU, and thus in Estonia, is valid for 5 years. Once the registration expires, manufacturers are obligated to apply for renewal if they plan to continue to market their device in Estonia, or in the European Union in general. Foreign manufacturers, or those that are not based in the EU, must appoint an Authorized Representative from any of the EU member states to handle registration applications.

Documents Required for Medical Device Registration

• A copy of the user manual in Estonian
• A copy of the original user manual
• A copy of the labelling or packaging
• EC-certificate
• A Declaration of Conformity
• Notification consists of submission of at least the following information:
  • The name and address of person responsible for placing a product on the Estonian market, responsible for distribution or put into service in Estonia
  • The name and address of manufacturer of medical devices and, if applicable the name and address of authorized representative in the EU
  • The name and intended purpose of the device in Estonian and English
  • The identification of the device (commercial name of the device, model or catalogue number).

Registration Timeline

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.

Registration Fee

No Fees

License Validity

5 Years

Special Labelling Requirements

The information on medical devices in Estonia must be presented in Estonian, with translations ensured by the distributor or marketer.

Additional Comments

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.

Market Overview

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.

When to make this communication?

Before placing a medical device into the market.

How OMC Medical can assist you with the process?

Why Choose Us?

• Working towards client satisfaction
• Cost effective solutions
• Project completion before deadline
• Quality Regulatory affairs solutions

Contact us for free consultation: info@omcmedical.co.uk