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Saatja: RA MSO </O=SOTSIAALMINISTEERIUM/OU=EXCHANGE ADMINISTRATIVE GROUP (FYDIBOHF23SPDLT)/CN=RECIPIENTS/CN=72F3C63240224E00B8EFA069E66B5C58-RA> Saaja: Elisa Giampietri, Regulatory Affairs - Materialise Belgium Teema: Vs: Distributor Notification Requirements under Estonian Medical Devices Act § 26 clarification Dear Elisa Giampietri, Currently, the Estonian MDA § 26 does set this obligation to each distributor that starts distribution – if the device is already in our database the next distributor will be added to the same entry. I will say that we have started with the process of reviewing the MDA and this will take some time, but there might be some changes in the future with the notification obligation and more. I would recommend coming back to this question sometime late 2026 – early 2027. I hope this is helpful, let me know if I can explain these obligations further. Best regards, Piret Põiklik Head of Department Department of Medical Devices State Agency of Medicines [email protected] <mailto:[email protected]> +372 5853 3610 1 Nooruse Street 50411 Tartu Estonia Phone: +372 737 4140 www.ravimiamet.ee <http://www.ravimiamet.ee/> This e-mail and any attachments transmitted may contain confidential and privileged information. If you are not the intended recipient, please notify the sender immediately by returning the e-mail and permanently deleting what you have recieved. Any dissemination or use of this information by a third person without permission is prohibited and may be illegal. Saatja: Elisa Giampietri <[email protected]> Saatmisaeg: neljapäev, 15. jaanuar 2026 16:21 Adressaat: RA MSO <[email protected]> Koopia: Regulatory Affairs - Materialise Belgium <[email protected]> Teema: Distributor Notification Requirements under Estonian Medical Devices Act § 26 clarification Tähelepanu! Tegemist on väljastpoolt asutust saabunud kirjaga. Tundmatu saatja korral palume linke ja faile mitte avada. Dear Agency of Medicines of the Republic of Estonia, My name is Elisa Giampietri, and I am a Regulatory Affairs Specialist at Materialise NV, Belgium. According to the Estonian Medical Devices Act § 26, every actor who distributes certain medical devices in Estonia must notify the State Agency of Medicines within 10 days after the first distribution of the relevant medical device via the Estonian Medical Devices and Appliances Database (EMDDB). In situations where the legal manufacturer is not located in Estonia and has already completed the required device notification in EMDDB before the product is distributed, would a distributor located in Estonia still be required to submit its own notification, or would the Legal manufacturer’s notification alone be considered sufficient to meet the legal requirements? Your clarification would be greatly appreciated to ensure correct understanding and compliance with Estonian regulatory obligations. Kind regards, Elisa Giampietri Regulatory Affairs Specialist Materialise NV (Belgium)