• Information for placing a new product on the market

Information for placing a new product on the market  

1. A Medical Device placed on the market or put into use in European Union is allowed to be sold in Estonia without notifying State Agency of Medicines, although it is recommended.

2. A Medical Device may be placed on the market or put into use only if the following conditions are met:

a) The Medical Device complies with the Medical Devices Act and other laws based upon it.
b) The Medical Device has been clinically evaluated and when necessary gone through clinical trials.
c) The Medical Device has been through conformity evaluation.
d) The Medical Device is supplied with information for identifying the manufacturer and insuring the safe and to the purpose usage 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.

3. If a manufacturer/representative/importer located in Estonia releases a class I product, custom made medical device, a system of medical devices, a system of procedures or an in vitro medical device to the EU market, it has to be notified to the State Agency of Medicines. In such a case a filled notification form has to be submitted (http://www.ravimiamet.ee/6036).
The following documents and data is required:

a) the full business name and address of the person responsible for placing a product on the market
b) the full business name and address of the manufacturer
c) the purpose of the medical device stated by the manufacturer
d) copy of a users manual *
e) copy of labelling
f) copy of the declaration of conformity
g) statement concerning devices for special purposes in case of custom made medical device
h) GMDN code (generic medical device nomenclature)
i) class of medical device
j) data identifying the medical device
k) the name of the medical device in Estonian

4. A Notified Body is responsible for the placing on the market of Medical devices of classes I sterile, I with measuring function, IIa, IIb and III

5. State Agency of Medicines will insert the received information to the electronic database in 10 days starting from the reception of correctly filled notification form and issues a certificate of notification.

6. The information on the selling package (including the product name, if applicable) has to be in Estonian. A good practice is to add the name and address of the distributor to the labelling, if the product is manufactures outside of Estonia.

7. The online database of medical devices is located:
http://bigsam2/msr/Forms/StartPage.aspx

8. The Medical Devices Act is located (in Estonian and in Russian):
http://www.legaltext.ee/en/andmebaas/document.asp?ptyyp=RT&pg=23&display=1&tyyp=X&query=act
in English:
http://www.legaltext.ee/et/andmebaas/tekst.asp?loc=text&dok=X90002&keel=en&pg=1&ptyyp=RT&tyyp=X&query=meditsiiniseadme+seadus

*) The minimal information concerning the placing on the market or putting into use of a medical device which ensures a safe and to the purpose use of the medical device, is displayed in Estonian and in an appropriate manner, taking into account the knowledge of the potential user. Other information concerning the medical device may be in any other EU memberstate language, provided it is understandable for the user.
NB! The same principles applies to products meant only for Estonian inner market.