Regulation
New medical-device technical regulations: aligned with EU MDR / IVDR
On 10 June 2026 the Cabinet of Ministers approved Resolutions No. 759 and No. 758 — technical regulations on medical devices and in vitro diagnostic devices, aligned with EU MDR and IVDR. The resolutions take effect six months after publication; the regulations themselves apply from 31 December 2030, with a transition period for manufacturers and facilities. KHAI-MEDICA works to ISO 13485 and already follows a conformity logic: we are preparing our functional-diagnostics systems and documentation for the new requirements.
