Medical Device Regulation in Hungary
Hungary regulates medical devices under the EU Medical Device Regulation (EU MDR 2017/745) as a member state of the European Union. The National Institute of Pharmacy and Nutrition (OGYÉI) is the national competent authority for medical devices. Hungary has a growing medical device industry and is fully integrated into the EU harmonized regulatory system.
Sources Tracked by Qalico
Qalico continuously monitors 1 references across guidelines, regulations, and standards for Hungary.
Guidelines
Device Classification
Hungary follows the EU MDR classification system. Class I devices are low risk (e.g., cold compresses, hospital furniture). Class IIa devices are low-moderate risk (e.g., dental materials, ultrasound diagnostic equipment). Class IIb devices are moderate-high risk (e.g., external cardiac defibrillators, orthopaedic screws). Class III devices are high risk (e.g., mechanical heart valves, absorbable vascular stents). Classification follows EU MDR Annex VIII.
Official classification guidance →Official Guidance Documents
Official OGYÉI portal for medical device regulation in Hungary, including regulatory guidance and vigilance reporting information.
The complete text of EU Regulation 2017/745 on medical devices, directly applicable in Hungary.
The European database for medical device registration, UDI management, and certificate information across all EU member states.
Standards & Key Principles
Applicable Standards
Key Principles
- Medical devices must bear the CE mark under EU MDR 2017/745 to be legally placed on the Hungarian market.
- EUDAMED registration and UDI compliance are mandatory.
- Notified body involvement is required for Class IIa, IIb, and III devices.
- Non-EU manufacturers must designate an EU-based authorized representative.
- Post-market surveillance and vigilance reporting to OGYÉI are mandatory.
- Clinical investigations require OGYÉI authorization and ethics committee approval.
Pre-Market Requirements
Compliance with EU MDR 2017/745 and CE marking are required. Notified body involvement is mandatory for Class IIa, IIb, and III devices.
Complete technical documentation per EU MDR Annexes II and III must be prepared, including device description, risk analysis, design verification, and clinical evidence.
Clinical evaluations are required for all device classes under EU MDR Article 61. Clinical investigations in Hungary require OGYÉI authorization and ethics committee approval.
Manufacturers must register in EUDAMED, including actor registration, UDI-DI assignment, and device information.
Post-Market Requirements
A PMS system must be implemented per EU MDR. Periodic safety update reports are required for Class IIa, IIb, and III devices.
Serious incidents and field safety corrective actions must be reported to OGYÉI in accordance with EU MDR Article 87 and national requirements.
PMCF activities must be conducted to proactively collect and evaluate clinical data, confirming ongoing safety and performance throughout the device lifecycle.
International Recognition & Reliance
As an EU member state, CE-marked devices under EU MDR are recognized across all EU/EEA markets.
CE-marked devices from EU member states are recognized in Switzerland under the Swiss-EU MRA framework.