Regulatory controls for medical devices
A medical device may only be placed on the market or put into use if the medical device:
- complies with the requirements in regulation (EL) 2017/745 or (EL) 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 a system or procedure pack of medical devices according to Regulation (EU) 2017/745 or a class IIa, IIb or III medical device or a class B, C or D in vitro diagnostic medical devices classified according to Regulation (EU) 2017/746, shall notify the Health Board within 10 days after distribution of the relevant medical device for the first time.
According to the Estonian Medical Devices Act, 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.
For further information on notification requirements please see § 26 of the Medical Devices Act.
Notifications to the Health Board are made through the online Estonian Medical Devices Database (EMDDB). Please see under section Help for details on notification process.