Küsimused

Saatja: RA MSO </O=SOTSIAALMINISTEERIUM/OU=EXCHANGE ADMINISTRATIVE GROUP (FYDIBOHF23SPDLT)/CN=RECIPIENTS/CN=72F3C63240224E00B8EFA069E66B5C58-RA> Saaja: Elisa Giampietri, Regulatory Affairs - Materialise Belgium Teema: Vs: Clarification on National Reprocessing Requirements for Reusable Medical Devices in Estonia Dear Elisa Giampietri, Thank you for contacting us. In addition to MDR and IVDR as well as other relevant EU legal acts the national provisions on medical devices compliance can be found in the Medical Devices Act <https://www.riigiteataja.ee/en/eli/503102025002/consolide> . MDA does not contain any specifics on the questions you have raised. 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: kolmapäev, 14. jaanuar 2026 11:10 Adressaat: RA MSO <[email protected]> Koopia: Regulatory Affairs - Materialise Belgium <[email protected]> Teema: Clarification on National Reprocessing Requirements for Reusable Medical Devices in Estonia Tähelepanu! Tegemist on väljastpoolt asutust saabunud kirjaga. Tundmatu saatja korral palume linke ja faile mitte avada. Dear Agency for Medicinal Products and Medical Devices of the Republic of Estonia, My name is Elisa Giampietri, Regulatory Affairs Specialist at Materialise (Belgium). I am contacting you to clarify whether Estonia has any specific national requirements or guidance documents related to the reprocessing of reusable medical devices in hospitals (e.g., cleaning, disinfection, sterilization parameters, such as the time of sterilization cycle, pH for cleaning agents, required Ao value) that manufacturers should consider in addition to MDR and EN ISO 17644-1. My review of your website did not reveal any documents, so I would like to inquire if the agency has any specific guidance that we need to comply with or consider. To avoid any misunderstanding, this inquiry concerns reusable devices, not single‑use devices addressed under Article 17 of the MDR. Thank you in advance for your assistance. Best regards, Elisa Giampietri Regulatory Affairs Specialist Materialise NV