Market Surveillance of Medical Devices in Estonia

1. Purpose and Principles

The State Agency of Medicines conducts market surveillance to ensure medical devices in use comply with requirements and do not threaten human health. Estonia follows the EU principle of free movement of goods, allowing compliant devices legally placed on the market in one member state to be sold and used in others without restriction unless justified. Source: Estonian State Agency of Medicines Market Surveillance Page https://www.ravimiamet.ee/en/medical-devices/medical-devices/market-surveillance

2. Manufacturer Responsibility

Manufacturers bear sole responsibility for ensuring product compliance with all requirements and successful completion of conformity assessment procedures. For higher-risk devices, notified bodies are involved in issuing certificates. Source: Estonian State Agency of Medicines Market Surveillance Page https://www.ravimiamet.ee/en/medical-devices/medical-devices/market-surveillance

3. Focus on Post-Market Activities

With no pre-market national control, the Agency emphasizes surveillance of devices already on the market and operating companies. Activities include:

• Advising users and companies.
• Checking reports of suspicious devices.
• Information exchange with other agencies (Tax and Customs Board, Consumer Protection and Technical Regulatory Authority) and member states.
• Handling non-compliances from inspections and checks.
• Surveillance of online sales and advertising.
• Disseminating safety notices and information.
• Authorization and surveillance of clinical investigations and performance studies. Source: Estonian State Agency of Medicines Market Surveillance Page https://www.ravimiamet.ee/en/medical-devices/medical-devices/market-surveillance

4. Obligations of Other Parties

Distributors, importers, EU authorized representatives, and service providers must ensure compliance before making devices available and during use. Source: Estonian State Agency of Medicines Market Surveillance Page https://www.ravimiamet.ee/en/medical-devices/medical-devices/market-surveillance

5. Additional Information

For more on EU single market principles, refer to the Blue Guide. Last updated: 03 February 2025. Source: Estonian State Agency of Medicines Market Surveillance Page https://www.ravimiamet.ee/en/medical-devices/medical-devices/market-surveillance