Overview of the Bulgarian Drug Agency (BDA) and Medical Device Regulation

Bulgarian Drug Agency (BDA) - Medical Devices Overview

The Bulgarian Drug Agency (BDA) is the specialized state regulatory body under the Ministry of Health of the Republic of Bulgaria. It acts as the national competent authority responsible for ensuring the quality, safety, and efficacy of medical devices and medicinal products on the Bulgarian market.

Key Roles and Responsibilities

The BDA manages the lifecycle of medical devices through several critical regulatory functions:

• Registration and Notification: Coordinates the registration of local manufacturers, authorized representatives, and the notification of medical devices and in vitro diagnostic medical devices (IVDs) placed on the market or put into service in Bulgaria, in compliance with the national Law on Medical Devices (MDL).
• Vigilance System: Coordinates the national materiovigilance network. The BDA collects and reviews Manufacturer's Incident Reports (MIR), Field Safety Corrective Actions (FSCAs), and issues Field Safety Notices (FSNs) to manage risks systematically.
• Clinical Investigations: Evaluates, authorizes, and monitors clinical investigations for medical devices and performance studies for IVDs conducted within the territory of Bulgaria.
• Market Surveillance: Conducts preventative and reactive inspections of economic operators (manufacturers, importers, distributors) and testing laboratories to ensure alignment with legal standards.

Regulatory Framework

The BDA executes its mandate aligned with harmonized European legislation:

• Medical Device Regulation (MDR) - Regulation (EU) 2017/745
• In Vitro Diagnostic Regulation (IVDR) - Regulation (EU) 2017/746
• Integrated locally via the Bulgarian Law on Medical Devices (MDL).