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.
- 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.
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