Küsimused

Dear Barbara,

Thank you for the inquiry.

The local distribution notification for medical devices comes from our national legislation, the Medical Devices Act, that states in §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.

The objective of this local notification is for us to gain knowledge of the devices that are being distributed locally in Estonia and as such this obligation will remain in place even after EUDAMED becomes fully functional and mandatory. At the moment we do not foresee a necessity to change the local legislation in relation to the implementation of EUDAMED. As you can see from the quotation above – devices in the lowest risk classes (class I and class A) are already excluded from this obligation in the Medical Devices Act so notification of devices of these risk classes is voluntary unless the notification obligation arises for other reasons e.g. specific contracts.

Please don’t hesitate to contact us again should you have any further questions.

Best regards

1 Nooruse Street
50411 Tartu
Estonia
Phone: +372 737 4140

www.ravimiamet.ee

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Dear Sir/Madam,

I am contacting you because I would like to have information about local notification, will continue  local notifications of devices  to be mandatory in Estonia  once the EUDAMED module is in place.?

If this is so, will the notifications  not be mandatory for all devices or for devices of certain classes ?  Will be the local legislation amended to reflect this?

I thank you in advance for your guidance.

Have a nice day!

Best regards,

Barbara Björkbom

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