In accordance with Article 14 of the Medical Devices Act (Official Gazette of the Republic of Slovenia [Uradni list RS], No 40/25; ZMedPri-1), the JAZMP may, upon receiving a proposal from a healthcare provider and subject to the conditions set out in Article 17 of Regulation 2017/745/EU and Article 14 of the Medical Devices Act (ZMedPri-1), decide to include a medical device intended for single use by its manufacturer on the list of devices authorised for reprocessing and further use in Slovenia.
The form and detailed content of the proposal are determined by the JAZMP, in agreement with the minister responsible for health, by means of a general act that is currently being drafted.
For a health institution that reprocesses single-use medical devices in accordance with Article 14 of the Medical Devices Act (ZMedPri-1), the provisions of Regulation 2017/745/EU relating to manufacturers’ obligations apply mutatis mutandis.
