Medical Device Registration in

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

Documents Required

  • CE Certificate
  • Technical File
  • Declaration of Conformity
  • Clinical Evaluation Report (CER)
  • Risk Management File
  • QMS certificate
  • Label, IFU and User Manual

Post-market Requirements

Serious public health threats – 2 day

Death or serious health deterioration – 10 days

Other serious incidents – 15 days

Applicable QMS

ISO 13485

Registration Timeline

Class I: 4-6 weeks

Others: Based on Notified Body timeline

Authorized Representative

Yes

License Validity

5 years

Special Notes

IFU and label of medical devices must be available in Hungarian.

 

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