Hungary: MDR implementation at national level

The Regulation (EU) 2017/745 on medical devices is implemented into Hungarian national legislation through amended Decree on the Regulation of Medical Devices 4/2009 EüM, clinical trials legislation, and designated organizations legislation.

National Regulatory Authority

Department for Medical Devices, National Institute of Pharmacy OGYEI is the Hungarian Competent Authority and Designating Authority of the Hungarian notified bodies for medical devices and in-vitro medical devices.

Registration under MDR

Since May 26, 2021, class I devices previously registered under Directive 93/42/EEC cannot be placed on the market and shall be registered . . .


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