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Regulatory controls for medical devices

Placing on the market

 

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

  • complies with the 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).
 

Notification procedure

 

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).
 

Online notification

 

Though it is still possible to use notification forms, more convenient and the most acceptable way is to present data through our online solution – Estonian Medical Devices Database (EMDDB). 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).
 

Releasing products to the EU market from Estonia

 

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.