Medical Device Registration in Hungary

1. Regulatory Authority

The Department for Medical Devices of the National Institute of Pharmacy (OGYEI) is the competent authority for medical device registration in Hungary. OGYEI ensures compliance with Medical Device Regulations and acts as the designating authority for Hungarian notified bodies. Source: OMC Medical Hungary Medical Device Registration Page https://omcmedical.com/hungary-medical-device-registration

2. Local Regulations

Key regulations include:

• Joint Decree on the Regulation of Medical Devices 4/2009 (III. 17.)
• Law on Market Surveillance of Medical Products 2012 Hungary follows EU regulations, with a single CE mark valid across the EU. Source: OMC Medical Hungary Medical Device Registration Page https://omcmedical.com/hungary-medical-device-registration

3. Classification

Medical devices are classified as Class I, IIa, IIb, and III under MDR. IVDs follow IVDR classifications. Source: OMC Medical Hungary Medical Device Registration Page https://omcmedical.com/hungary-medical-device-registration

4. Registration Requirements

Registration is mandatory for:

• Class I medical device manufacturers and their devices in Hungary.
• Custom-made device manufacturers and their devices in Hungary.
• IVD manufacturers and their devices in Hungary.
• IVD distributors in Hungary.
• IVD performance evaluations.
• Persons assembling systems/procedure packs or sterilizing devices in Hungary. Non-EU manufacturers must appoint an EU Authorized Representative. Source: OMC Medical Hungary Medical Device Registration Page https://omcmedical.com/hungary-medical-device-registration

5. Documents Required

• Technical documentation.
• Declaration of conformity.
• CE certificate (if applicable).
• Proof of Authorized Representative.
• Labeling and IFU (Hungarian for safety warnings and IFU).
• UDI information. Source: OMC Medical Hungary Medical Device Registration Page https://omcmedical.com/hungary-medical-device-registration

6. Registration Procedure and Timeline

Submit application to OGYEI. Process takes 4-6 weeks for Class I after submission. Higher classes depend on notified body contract. QMS (e.g., ISO 13485) certification is required, valid for 3 years. Source: OMC Medical Hungary Medical Device Registration Page https://omcmedical.com/hungary-medical-device-registration

7. License Validity and Fees

Registration valid for 5 years, renewable. Fees vary by class; higher for Class III and implantables. No specific fee amounts listed. Source: OMC Medical Hungary Medical Device Registration Page https://omcmedical.com/hungary-medical-device-registration

8. Special Labeling Requirements

International symbols and English allowed, but IFU and safety warnings must be in Hungarian. Source: OMC Medical Hungary Medical Device Registration Page https://omcmedical.com/hungary-medical-device-registration

9. Who Must Register

Manufacturer or Authorized Representative before market placement. Source: OMC Medical Hungary Medical Device Registration Page https://omcmedical.com/hungary-medical-device-registration