National Agency for Medicines and Medical Devices of Romania (ANMDMR) - Overview

The National Agency for Medicines and Medical Devices of Romania (ANMDMR), also known in English as NAMMDR, is the national competent authority responsible for regulating and supervising medical devices and human medicinal products within Romania. Operating under the Ministry of Health, its core mission is to protect and promote public health by ensuring that all medical technology complies with stringent European standards.

Key Roles and Responsibilities

ANMDMR oversees multiple life-cycle areas of medical devices:

1. Market Registration and Notifications

• National Database: Manages the registration of medical devices (Classes I, IIa, IIb, III, active implantables, and IVDs) placed on the Romanian market or put into service.
• Economic Operators: Ensures domestic manufacturers, authorized representatives, importers, and distributors are appropriately tracked in national registers and synchronized with the European EUDAMED database.

2. Market Surveillance and Audits

• Conducts preventative and reactive inspections of domestic economic operators to check conformity.
• Evaluates devices currently in use across both public and private healthcare networks to ensure proper maintenance and performance.
• Reviews medical technology advertising directed at healthcare professionals and the public.

3. Vigilance and Incident Reporting

• Oversees the materiovigilance network in Romania.
• Receives and processes Field Safety Corrective Actions (FSCAs) and adverse incident reports submitted by manufacturers, medical professionals, or users to systematically mitigate patient health risks.

4. Clinical Investigations & Performance Evaluation

• Approves authorizations for conducting clinical trials or clinical investigations for medical devices.
• Performs scientific and compliance assessments for performance evaluations of in vitro diagnostic medical devices (IVDs).

Regulatory Framework

As Romania is an EU Member State, ANMDMR executes mandates aligned with:

• Medical Device Regulation (MDR) - Regulation (EU) 2017/745
• In Vitro Diagnostic Regulation (IVDR) - Regulation (EU) 2017/746
• National framework applications, such as Emergency Government Ordinance no. 46/2021 and Minister of Health Orders (e.g., Order 3539/2022).