Hungary

Ministry of Health

Hungary – Ministry of Health

Regulatory Authority

Department for Medical Devices, National Institute of Pharmacy

Medical Device Regulation

EU MDR 2017/745

Official Language

Hungarian

Classification

Class I, IIa, IIb and III

Registration Process

• Obtain CE Marking certificate.
• Appoint Authorized Representative.
• Determine class of the device.
• Class I device can be Self-Certified. QMS necessary but Notified Body intervention is not required.
• For other classes, prepare a CE Technical File
• Obtain and register UDI in EUDAMED.
• Technical File should be audited by Notified Body.
• Prepare a Declaration of Conformity.
• Once approved, the device can be marketed in Hungary