Overview of the Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (JAZMP)
An overview of JAZMP, the national competent authority in Slovenia responsible for medical device registration, market surveillance, and materiovigilance under the EU MDR/IVDR framework.
Overview
Summary of this regulator or jurisdiction and how it relates to market access.
Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (JAZMP) - Overview
The Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (JAZMP) (Javna agencija Republike Slovenije za zdravila in medicinske pripomočke) is the independent regulatory authority responsible for supervising medical devices and medicinal products for human and veterinary use in Slovenia. As a member of the European regulatory network, JAZMP ensures that all medical technologies meet safety, quality, and efficacy criteria.
Key Roles and Responsibilities
JAZMP executes several critical regulatory functions across the lifecycle of medical devices:
- Registration of Economic Operators: Manages the registry of manufacturers, authorized representatives, importers, and distributors established within the territory of Slovenia.
- Device Notification: Oversees the entries of medical devices into national databases, ensuring that conformity assessments and technical certifications are validated before products are placed on the market or put into service.
- Market Surveillance: Conducts regular, random, or reactive facility inspections and audits of economic operators and health institutions to verify continuous compliance with manufacturing, distribution, and clinical handling protocols.
- Materiovigilance (Vigilance System): Serves as the central collection point for monitoring adverse events, serious incidents, and device malfunctions. It reviews Field Safety Corrective Actions (FSCAs) and ensures dissemination of Field Safety Notices (FSNs).
- Clinical Investigations: Evaluates and issues regulatory approvals for conducting clinical investigations of medical devices and performance studies of in vitro diagnostic medical devices (IVDs) in Slovenian medical environments.
Regulatory Framework
JAZMP strictly enforces regulations aligned with unified European criteria:
- Medical Device Regulation (MDR) - Regulation (EU) 2017/745
- In Vitro Diagnostic Regulation (IVDR) - Regulation (EU) 2017/746
- Medical Devices Act (Zakon o medicinskih pripomočkih) of Slovenia, integrating the local execution framework.
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