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Saatja: Elisa Giampietri <[email protected]> Saaja: RA MSO, Regulatory Affairs - Materialise Belgium 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)