Font size
Font spacing
Contrast
Terviseamet

Estonian Regulatory Authority
Estonian Health Board
Paldiski Maantee 81
10617 Tallinn
Estonia
www.terviseamet.ee
Medical Devices Department
Põllu 1a                                                 e-mail: mso@terviseamet.ee
50303 Tartu                                          
Estonia
 

Ms Tagne Ratassepp – Head of Department
Questions concerning legislation, other general issues in relation to medical devices, Custom notifications
Phone: +372 580 943 39

Regulatory controls
A medical device may only be placed on the market or put into use if the medical device:
  • complies with the MDR and Medical Devices Act and other laws based upon it;
  • has been clinically evaluated and, when necessary, undergone clinical trials;
  • has been through conformity evaluation;
  • is supplied with information for identifying the manufacturer and ensuring the safe and appropriate use of the product (such information must be on every medical device, package of every unit of the medical device, or both, or the marketing package of the medical device).
There is an obligation to involve Notified Body to perform procedure of overseeing the conformity of medical devise in class I sterile and/or with measuring function, class IIa, IIb and III or active implanted medical devices. At the present time there is no NB for medical devices in Estonia.
A medical device placed on the market or put into use in the European Union is allowed to be sold in Estonia, although there is a requirement for notification if the device is in Class IIa, IIb, III or AIMD (§ 26 of Medical Device Act); the notification of Class I devices and in vitro diagnostic medical devices is also recommended.
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 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.
In addition, if the device is put into service, the application should include the following information:
  • the name and address of health service provider;
  • data identifying the medical device (additionally to mentioned above – serial / batch / LOT number).
If a manufacturer / Authorised Representative / importer 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;
  • Global Medical Device Nomenclature code.
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 (or on demand on the paper) confirmation letter.
There are no fees for registration or adding medical devices to the national medical devices database.
Labelling & language requirements
Language requirements for medical devices in Estonia can be found in Medical Devices Act § 16 and it is written as following: The information strictly necessary for the safe use of a medical device for its intended purpose accompanying a medical device to be placed on the market, distributed and put into service in Estonia shall be presented in the Estonian language and in an appropriate manner, taking account of the knowledge of the potential user of the device. The remaining information accompanying a device may be presented in another language of a Member State of the European Economic Area understandable to the potential user. The person who places the medical device on the market in Estonia or the distributor shall ensure the correctness of translation of the instructions of a medical device.
 
Ethics Committees in Estonia

1. Tallinn Medical Research Ethics Committee of the National Institute for Health Development
Hiiu 42
11619 Tallinn
Estonia
Tel +372 659 3924
Fax +372 659 3901
e-mail: marje.liibek@tai.ee

2. Ethics Review Committee on Human Research of the University of Tartu
(Office of Research and Development)
Ülikooli 18 - 304
50090 Tartu
Estonia
Tel: +372 737 5514
Fax: +372 737 5508
E-post: eetikakomitee@ut.ee

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 5050
Email: info@evs.ee
Website: www.evs.ee


Piksel

x
Database News Help Forms Open data