Küsimused

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