Supervision on the implementation of the Act on Medical Devices

JAZMP pharmaceutical inspectors are the competent authority for the supervision of the field of medical devices on the basis of the provisions of the Act on Medical Devices (Official Gazette of the Republic of Slovenia [Uradni list RS] No. 98/09, hereinafter: ZMedPri) and executive acts therein.

Supervision is done on routine and non-routine basis, based on the risk analysis of information received through various notifications, reports, media, routine inspections, and other activities within JAZMP.

JAZMP is conducting inspections at manufacturers of medical devices based in the Republic of Slovenia, at wholesale and retail distributors based in the Republic of Slovenia, and at importers of medical devices based in the Republic of Slovenia. JAZMP is also the competent authority for the supervision of medical devices in use in the Republic of Slovenia, including healthcare providers and other liable persons providing medical devices for use. JAZMP also performs supervision of the execution of clinical trials in the field of medicinal devices, activities of the notified body based in the Republic of Slovenia, and market surveillance of medicinal devices in the Republic of Slovenia.

Supervision in the field of medical devices coverts the ascertaining the compliance for performing the activities of manufacturing and marketing of medicinal devices (suitability of personnel, premises, equipment, documentation, manufacturing processes, and other legislative requirements), verification of conformity of medical devices on the market and in use (CE label, EC declaration of conformity, EC certificate, instructions for use, etc.), determination of suitability of medical device advertising, ascertaining the compliance of the vigilance system participants with the vigilance requirements, verification of the suitable maintenance of medical devices in use, and supervision over the implementation of other provisions of ZMedPri.

JAZMP is the minor offence authority in the field of medical devices.