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Terviseamet
FOR VISUALLY IMPAIRED

Estonian Regulatory Authority
Estonian Health Board
Paldiski Maantee 81
10617 Tallinn
Estonia
www.terviseamet.ee

Medical Devices Department
Paju 2                                                e-mail: mso@terviseamet.ee
50603 Tartu                                          
Estonia

Ms Piret Põiklik – Head of Department
Questions concerning legislation, other general issues in relation to medical devices
Phone: +372 5853 3610

National law for medical devices in Estonia is Medical Devices Act

Regulatory controls / Notification procedure

A medical device may only be placed on the market or put into use if the medical 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.

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 Health Board within 10 days after distribution of the relevant medical device for the first time.

The notification of Class I devices is also recommended.

Notifications to the Health Board are made through the online Estonian Medical Devices Database (EMDDB).

To use the database properly please use a short guide for using the Estonian Medical Device Database that can also be found on database homepage under „Forms“.


Notification of submission consists 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 authorised 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).
With the completed notification form a distributor must provide:
  • a copy of the user manual in Estonian;
  • a copy of the original user manual;
  • a copy of the labelling or packaging.

If a manufacturer / Authorised Representative located in Estonia releases a Class I product, custom-made medical device, a system or a procedure pack, or an in vitro diagnostic medical device to the European Union market, it has to be registered in the Estonian Health Board using the relevant notification form. Notifications should include the following documents and data:
  • the full business name and address of the person responsible for placing a product on the EU market;
  • the full business name and address of the manufacturer and, if applicable, the name and address of the authorized representative;
  • data identifying the medical device (commercial name of the device, model or catalogue number);
  • the name of the medical device in Estonian and English;
  • class of the medical device;
  • the intended purpose of the medical device as stated by the manufacturer in Estonian and English.
With the completed registration form a distributor must provide:
  • a copy of the Declaration of Conformity;
  • a copy of the user manual in Estonian;
  • a copy of the original user manual;
  • a copy of the labeling or packaging;
  • a statement concerning devices for special purposes in case of custom-made medical devices.

The Estonian Health Board will add the received information to the electronic database within 10 days of receiving a correctly completed notification form and then will issue an electronic confirmation letter.

There are no fees for registration or adding medical devices to the national medical devices database.
 
Implementation of obligations and requirements related with European database on medical devices (EUDAMED)
According to the Estonian Medical Devices Act §41^2, until the implementation date of the obligations set out in points d and e of subsection 3 of Article 122 of Regulation (EU) 2017/745 and in points a and f 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 Health Board and the transmission of data to the Health Board 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
 
Labelling & language requirements

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.

Standards organisation in Estonia

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


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