Medical devices include all products that are used for the diagnosis, prevention, monitoring, treatment, and alleviation of disease, handicap, invalidity, anatomic functions or physiological processes, birth control, and which do not achieve their principal intended action in or on the human body by pharmacological, immunological or metabolic means. This means that medical devices are everything from simple bandages to electromagnetic and mechanical devices for hospital use, surgical instruments and diagnostic tests.
Medical devices are divided into:
- “general” medical devices,
- active implantable medical devices, and
- in vitro diagnostic medical devices,
and are classified according to the risk level for the user, location and method of use, connection to power source, duration of use, and other characteristics. A medical device must bear a CE marking when placing on the market. This is acquired by undergoing the conformity assessment procedure to comply with the essential requirements set out in regulations of the Republic of Slovenia and of the European Union governing this field. More is available in section Legislation in the field of medical devices.
JAZMP as the competent authority for medical devices of the Republic of Slovenia performs regulatory and surveillance functions in the entire field of medical devices on the Slovenian market. This includes activities related to the classification of products as medical devices, to essential requirements for medical devices, to clinical investigations of medical devices and performance evaluation studies, to the vigilance system for medical devices and to the notified bodies for conformity assessment. JAZMP supervises manufacturers or their authorised representatives, and wholesale and retail suppliers of medical devices if they meet the conditions for performing this activity in accordance with current legislation, and performs other types of control with the purpose of protecting public health and assuring the safety of medical devices in the Republic of Slovenia. Expert counselling is provided to clients regarding the delimitation and classification of medical devices, and instructions for use or labelling.
In accordance with the duties performed, various publicly accessible registers are maintained:
- Register of medical devices whereof the manufacturer or his authorised representative has a registered office in the Republic of Slovenia,
- Register of manufacturers of medical devices with a registered office in the Republic of Slovenia,
- Register of legal entities wholesaling medical devices,
- Register of specialised stores retailing medical devices,
- List of notified bodies with a registered office in the Republic of Slovenia.
The aforementioned registers and the list can be found in section Registers and lists in the field of medical devices.
More information about the operation and arrangement of the medical devices market is available at the website of the European Commission.