Küsimused

Dear Annamaria Mastropietro,

Thank you for your enquiry.

National requirements for medical devices are established in the Medical Devices Act. There is a distribution notification obligation for medical devices in Estonia and it is set out in the Medical Devices Act, §26 (4):

Every undertaking who distributes on the market of Estonia a system or procedure pack of medical devices according to Article 22 of Regulation (EU) 2017/745 of the European Parliament and of the Council or a class IIa, IIb or III medical device classified according to Regulation (EU) 2017/745 of the European Parliament and of the Council or Council Directive 90/385/EEC on the approximation of the laws of the Member States relating to active implantable medical devices (OJ L 189, 20.07.1990, p 17–36) or Council Directive 93/42/EEC concerning medical devices (OJ L 169, 12.07.1993, p 1–43) or class B, C or D in vitro diagnostic medical devices classified according to Annex VIII of Regulation (EU) 2017/746 of the European Parliament and of the Council, shall notify the State Agency of Medicines thereof within 10 days after distribution of the relevant medical device for the first time.

Notification about distribution can be completed through our national Medical Devices and Appliances Database, https://msa.sm.ee/eng

Best regards,

Maarika Ojala

Specialist

Department of Medical Devices

State Agency of Medicines

[email protected]

1 Nooruse Street

50411 Tartu

Estonia

Phone: +372 737 4140

www.ravimiamet.ee

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