State Agency of Medicines
Nooruse 1

50411 Tartu
Estonia
https://www.ravimiamet.ee/

For questions, comments, or inquiries, please contact the Medical Devices Department of the State Agency of Medicines at mso@ravimiamet.ee   

The EU regulation (EU) 2017/745 on medical devices and (EU) 2017/746 on in vitro diagnostic medical devices are directly applicable in Estonia.

Any national additions and specifications can be found in the national Medical Devices Act.

The guidelines by the Medical Devices Coordination Group should be followed.

Any medical device may only be placed on the Estonian market or put into use if the device:

• complies with the requirements in regulation (EU) 2017/745 or (EU) 2017/746 or is placed on the market in accordance with the transitional provisions in these regulations;
• complies with the Medical Devices Act and other relevant legal acts.

According to the Estonian Medical Devices Act § 26 every actor who distributes in Estonia:

• system or procedure pack of medical devices according to Article 22 of Regulation (EU) 2017/745;
• IIa, IIb or III medical devices classified according to Regulation (EU) 2017/745 or Council Directive 93/42/EEC;
• ​active implantable medical devices according to Council Directive 90/385/EEC;
• class B, C or D in vitro diagnostic medical devices classified according to Annex VIII of Regulation (EU) 2017/746

​shall notify the State Agency of Medicines within 10 days after distribution of the relevant medical device for the first time.

The notification of Class I, Class A devices is recommended, but not mandatory.

Every actor who makes available on the Estonian market a custom-made medical device, has to register the device with the Estonian State Agency of Medicines.

Notifications to the State Agency of Medicines are made through the online Estonian Medical Devices and Appliances Database (EMDDB).
 
There are no fees for registration or adding medical devices to the national medical devices database.

According to the Estonian Medical Devices Act §41^2, until the implementation date of the obligations set out in subsection 3 of Article 122 of Regulation (EU) 2017/745 and of subsection 3 of Article 113 of Regulation (EU) 2017/746 of the European Parliament and of the Council related with the European database on medical devices, the exchange of information with the State Agency of Medicines and the transmission of data to the State Agency of Medicines takes place according to the wording of the Medical Devices Act in force prior to entry into force of the wording on 01.01.2023.

Previous wording (prior to 01.01.2023) of Estonian Medical Devices Act can be found here. 

According to the Estonian Medical Devices Act, the manufacturer of the medical device, relying on risk analysis, ascertains the information necessary for the safe use of a device for the intended purpose. The information accompanying the medical device being placed on the market, made available on the market, distributed and put into service in Estonia must be presented:

• in the Estonian language and in an appropriate manner if the medical device is intended for the use of lay users;
• in the Estonian or English language and in an appropriate manner if the medical device is intended only for the use of professional users;
• in the language understandable to a specific user and in an appropriate manner in case of a custom-made medical device.

It is important to keep in mind that the professional user and the supplier of the medical device should agree beforehand in case the information accompanying the medical device will only be provided in English. The professional user still has the right to demand that the relevant information is made available in Estonian.

For medical devices that are placed on the market in compliance with regulation (EU) 2017/745 or (EU) 2017/746 the requirements for labelling and translation set out in these regulations must be met. This includes the requirements set out in Articles 16 in both regulations.

Estonian Centre for Standardisation and Accreditation / Eesti Standardimis- ja Akrediteerimiskeskus MTÜ

Akadeemia tee 21/6
Tallinn 12618
Estonia
Tel: +372 605 5060
Email: standard@evs.ee
Website: www.evs.ee