Overview of Medical Device Regulation in Estonia

1. Applicable EU Regulations

Medical devices and in vitro diagnostic medical devices (IVDs) in Estonia are governed directly by:

• Regulation (EU) 2017/745 on medical devices (MDR)
• Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR) These regulations cover requirements for placing devices on the market, conformity assessment, and post-market obligations. Source: Estonian State Agency of Medicines Regulation Page https://www.ravimiamet.ee/en/medical-devices/medical-devices/regulation-field-medical-devices-estonia

2. National Legislation

The Estonian Medical Devices Act provides national additions and specifications to the EU regulations. Transitional provisions related to EUDAMED maintain previous national requirements until full implementation. Source: Estonian State Agency of Medicines Regulation Page https://www.ravimiamet.ee/en/medical-devices/medical-devices/regulation-field-medical-devices-estonia

3. Competent Authority

The State Agency of Medicines (Ravimiamet) is the competent authority responsible for oversight, including receiving notifications and registrations through the Estonian Medical Devices and Appliances Database (EMDDB). There are no fees for registration or notifications. Contact: medicaldevices@ravimiamet.ee Source: Estonian State Agency of Medicines Regulation Page https://www.ravimiamet.ee/en/medical-devices/medical-devices/regulation-field-medical-devices-estonia

4. Notification Obligations

Distributors must notify the Agency within 10 days of first distribution for higher-risk devices, including:

• Class IIa, IIb, III medical devices
• Active implantable devices
• Class B, C, D IVDs
• System or procedure packs Notification for Class I or Class A devices is recommended but not mandatory. Custom-made devices require notification at least 10 days before placing on the market. Source: Estonian State Agency of Medicines Regulation Page https://www.ravimiamet.ee/en/medical-devices/medical-devices/regulation-field-medical-devices-estonia

5. Transition to EUDAMED

Until EUDAMED obligations are fully implemented (expected 28 May 2026), national notification via EMDDB continues. After implementation, manufacturer and device registration (except custom-made) will shift to EUDAMED, while distributor notifications and custom-made device registrations remain national. Source: Estonian State Agency of Medicines Regulation Page https://www.ravimiamet.ee/en/medical-devices/medical-devices/regulation-field-medical-devices-estonia

6. Compliance Requirements

Devices must comply with MDR or IVDR (including transitional provisions) and the Medical Devices Act to be placed on the Estonian market or put into service. Guidance from the Medical Devices Coordination Group (MDCG) should be followed. Source: Estonian State Agency of Medicines Regulation Page https://www.ravimiamet.ee/en/medical-devices/medical-devices/regulation-field-medical-devices-estonia