Overview of the National Center for Public Health and Pharmacy (NNGYK) and Medical Device Regulation in Hungary

National Center for Public Health and Pharmacy (NNGYK) - Medical Devices

The National Center for Public Health and Pharmacy (NNGYK), formerly known as OGYÉI (National Institute of Pharmacy and Nutrition), is the national competent authority (CA) for medical devices and in vitro diagnostic (IVD) devices in Hungary. Since August 1, 2023, NNGYK has assumed all regulatory and supervisory roles for medical technology to ensure patient safety and product efficacy.

1. Key Roles and Responsibilities

NNGYK performs several critical functions as the state administration body:

• Market Surveillance: Conducting inspections and audits to ensure that medical devices on the Hungarian market comply with safety and performance requirements.
• Vigilance (Materiovigilance): Collecting and evaluating reports of serious adverse incidents and Field Safety Corrective Actions (FSCA) to mitigate risks to users.
• Economic Operator Registration: Managing the national register (NOR) for manufacturers, importers, and distributors operating in Hungary.
• Designating Authority: Authorizing and supervising Notified Bodies located in Hungary that certify medical devices.
• Clinical Investigations: Evaluating and authorizing applications for clinical investigations and performance studies.

2. Regulatory Framework

Hungary follows the harmonized European Union framework:

• Regulation (EU) 2017/745 (MDR) and Regulation (EU) 2017/746 (IVDR).
• Local Legislation: Decree 4/2009 (III. 17.) EüM on medical devices and the Law on Market Surveillance of Medical Products.

3. Language and Labelling Requirements

To ensure the safe use of devices in Hungary:

• Hungarian Language: Instructions for Use (IFU) and labels must be provided in Hungarian.
• Software/GUI: The user interface may be in English, provided the IFU includes detailed Hungarian screenshots and explanations.