Medical Device Registration in Slovenia
Medical devices intended for placement on the Slovenian market must comply with Regulation (EU) 2017/745 on Medical Devices (MDR) and Regulation (EU) 2017/746 on In Vitro Diagnostic Medical Devices (IVDR). These regulations establish the requirements for safety, performance, and market access for medical devices within the European Union.
Competent Authority
The competent authority responsible for medical device regulation in Slovenia is the Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (JAZMP). This authority is responsible for overseeing regulatory compliance, maintaining medical device registers, and conducting market surveillance activities.
CE Marking
Prior to placing a medical device on the Slovenian market, the device must undergo a conformity assessment procedure in accordance with the applicable European regulations. Upon successful completion of this assessment, the manufacturer may affix the CE marking to the device. The CE marking confirms that the device meets the relevant European regulatory requirements and may be legally marketed within the European Economic Area.
National Registration
Manufacturers or authorised representatives must ensure that medical devices are appropriately registered with the national authority where applicable. During the transitional period preceding the full implementation of the European Database on Medical Devices (EUDAMED), certain national registration procedures may continue to apply.
Post-Market Obligations
Manufacturers are required to comply with post-market surveillance and vigilance obligations. These responsibilities include continuous monitoring of device safety and performance, as well as the reporting of serious incidents to the competent authority.
