The planned measures are aimed at strengthening institutional capacity and human resources, optimising work processes and the functional responsibilities of staff within the Medical Devices Directorate, as well as developing and digitising electronic platforms for the submission and review of dossiers.
As part of this process, the agency has launched public consultations on a draft Order approving administrative procedures and Implementation Guidelines for the notification and registration of medical devices in the State Register of Medical Devices. The aim of the draft is to facilitate the recognition of medical devices bearing the CE marking and to simplify the registration processes for products that have already been assessed for compliance with European Union requirements, thereby reducing the administrative burden on economic operators.
At the same time, a draft Law on Medical Devices and In Vitro Diagnostic Medical Devices, as well as the subordinate regulations necessary for its implementation, are currently being finalised. The aim of these measures is to bring the national regulatory framework into line with EU legislation.
