The role of the Department for Medical Devices
as a law enforcement national Authority

1. Supervises the national market of medical devices in cooperation with the National Public Health and Medical Officer Service (Allami Nepegeszsegugyi es Tisztiorvosi Szolgalat) and the Hungarian Authority for Consumer Protection (Nemzeti Fogyasztóvédelmi Hatóság) in respect of fulfilling the Essential Requirements of placing devices on the market. Takes appropriate actions against the devices violating the relevant regulation with suspending the use or distribution, or withdrawing them from the market.
   
2. Maintains registers of medical devices manufacturers or authorised representatives if the manufacturer is Hungarian or from a third country and issues written acknowledgement about the registration.
   
   
3. Supervises and maintains register of devices intended for clinical investigations.
   
   
4. Supervises manufacturers and distributors of medical devices.
   
   
5. Authorises and maintains register of notified organisations allowed to carry out periodical inspection.
   
   
6. Resolves disputes between manufacturers and Notified Bodies resulting from the application of the classification rules.
   
   
7. In order to fulfil public health interests or therapeutic purpose for medically justified request, the Authorithy is authorised to make exceptions and grant licences for
   putting a medical device into service or use of a specific device that have not been submitted to the conformity assessment procedure.
   
   
8. Manages the secretary affairs of the Designation Committee who designates Notified Bodies and supervises the activity of the Notified Bodies.
   
   
9. Participates in legislation concerning medical devices and in the acception of European standards.
   
   
10. Participates in supervision of promotion of medical devices.

The procedure of the Department shall be governed by the Act CXL of 2004 on the General Rules of Administrative Offical Procedures and Services.

At the moment the Department deals mostly with domestic cases however as one of the Member States of the EU Hungary is obliged to fulfil the same obligations as the Member States in the territory of Hungary, notifying the fellow Competent Authorities of the EU about the resolutions.

In the meantime the Department has close connections with the fellow Competent Authorities of the European Community keeping the registers accessible for each other to synchronize the law enforcement and market surveillance tasks of the common market. The Hungarian Authority regularly consults with the Medical Device Sector of the EU Committee and participates in the activity of EC Expert- and Working Group Meetings.