Küsimused

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.

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]
+372 5853 3610

1 Nooruse Street
50411 Tartu
Estonia
Phone: +372 737 4140

www.ravimiamet.ee

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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