Hungary Medical Device Registration

Medical Device Registration in Hungary: OGYEI, Regulations, and Market Insights

Updated on 26/01/24

Regulatory Authority:Department for Medical Devices, National Institute of Pharmacy

OGYEI is the Hungarian Competent Authority for medical devices and in vitro medical devices. The Competent Authority is authorized to act on behalf of the Hungarian government of the member state to ensure that the requirements of the Medical Device Ragulations are applied.

OGYEI is also the Designating Authority of the Hungarian notified bodies which can certify medical devices. The Designating Authority is a body which has the authorization to designate and control the notified bodies located in Hungary.

Their aim is to make sure that medical devices are as safe as possible and that they work as intended.

Link for Regulatory Authority:https://ogyei.gov.hu/medical_devices

Local Regulation:

• Joint Decree on the Regulation of Medical Devices 4/2009 (III. 17.)
• Law on Market Surveillance of Medical Products 2012

Overview:

Harmonizing with the new EU medical device regulation, manufacturers must meet specific requirements before marketing their devices in the European Union. CE marking, indicating conformity with EU regulations, particularly the EU MDR and IVDR, is mandatory for all medical devices in the EU. Importantly, a single CE mark obtained in one member state is recognized in all EU member states, allowing manufacturers to market their devices across various countries without the need for individual approvals.

The registration process duration varies based on the device class, with Class I devices typically having a quicker process compared to higher-risk Class III devices. Manufacturers are obligated to implement a Quality Management System (QMS), commonly demonstrated through ISO 13485 certification, valid for three years. Licenses issued in Hungary and other EU states have a 5-year validity.

Foreign manufacturers outside the EU must appoint an Authorized Representative (AR) to facilitate the registration process in the desired EU country. Labeling requirements permit the use of international symbols and general information in English, but instructions for use and safety warnings must be provided in Hungarian. The device’s name and description are mandatory on labels before market placement.

In Hungary, medical devices play a crucial role in the broader healthcare framework, underscoring their significance in ensuring quality healthcare services.

Classification:Class I, IIa, IIb and III

Listing or Registration Requirements:

Registration of:

• Class I medical device’s manufacturer if it is inHungary and their devices
• Custom made device’s manufacturers if it is inHungary and their devices
• IVD’s manufacturer if it is in Hungary and their devices
• IVD’s distributor who acts in Hungary
• IVD’s performance evaluations
• Or natural or legal person who puts devices into system or procedure packs or sterilizes them if it is in Hungary

Documents Required:Medical devices in the EU must be CE-marked, conforming to EU regulations. Manufacturersdo not need to request new markings for each EU country they want to market their device in, as once granted,it is valid in all EU member states.

Registration Timeline:The registration process takes about 4-6 weeks after submission for Class I devices. For the other classes, it depends on the contract with the notified body and the type of device

License Validity:5 Years

Special Labelling Requirements:IFU and label of medical devices must be available in Hungarian

Who should make this communication:

• Manufacturer
• Authorized Representative

When to make this communication: Before placing a medical device into the market.

How OMC Medical can assist you with the process

• Act as your Authorized representative

Why Choose Us

• Working towards client satisfaction
• Cost effective solutions
• Project completion before deadline
• Quality Regulatory affairs solutions

Contact us for free consultation: [email protected]