Kiri

Dear Sam,

Thank you for your enquiry.

As an authorised representative located in Estonia you have to follow our national requirements until EUDAMED is fully functional. National law for medical devices in Estonia is Medical Devices Act, https://www.riigiteataja.ee/en/eli/515032023005/consolide.

More specifically, Medical Devices Act § 41² Implementation of obligations and requirements related with European database on medical devices

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 this wording.

The aforementioned transmission of data occurs through the national Medical Device Database, https://msa.sm.ee/eng

As it can be read, it also refers to the wording of the Medical Device Act in force prior to entry into force of this wording. The prior wording can be found here:

https://www.riigiteataja.ee/en/eli/ee/503022022001/consolide

Relevant point for you as an AR is § 26 (1) Notification of placing of medical devices on market and forwarding of information on medical devices already on market

Any person who places a class I medical device, custom-made medical device, system of medical devices, procedure pack or in vitro diagnostic medical device on the market in Estonia, shall notify, at least ten days before the medical device is placed on the market, the Health Board of the intention to place the medical device on the market and of any significant alterations of the medical device.

Therefore, if you have aforementioned devices (in bold) that you are acting as an AR, you have to notify us at least ten days before the medical device is placed on the market.

EUDAMED can be used as a voluntary until it is mandatory and for that I suggest you to use information and user guides that can be found on Commission website at https://health.ec.europa.eu/medical-devices-eudamed_en.

I would suggest that you acquaint yourself with the entire Medical Devices Act in order to be informed about any applicable local requirements and obligations.

Please do not hesitate to contact me for further information or any questions.

Best regards,

Karl Kalev Türk

Chief Specialist

Department of Medical Devices

Phone +372 5648 5663

[email protected] | [email protected] 

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