MDR implementation at national level
The regulation (EU) 2017/745 on medical devices is applied into Hungarian country with wide legislation via amended Decree on the regulation of medical devices 4/2009 EüM, clinical trials rules, and designated organizations legislation.
Countrywide Regulatory Authority
Department for Medical Devices, National Institute of PharmacyOGYEIis the Hungarian Competent Authority and Designating Authority of the Hungarian notified bodies for medical devices and in-vitro medical devices.
Registration under MDR
在这个帐户,5月26日,2021年,类我设备formerly registered under Directive 93/42/EEC cannot be located in the marketplace and will be registered following the regulation (EU) 2017/745 (MDR). An exception to that obligation are devices falling under Article 120 of MDR, such as class I devices with valid Notified Body Certificates under the Directives or devices up-categorized underneath the MDR. The device can be freely marketed in Hungary when the conformity assessment technique is carried out in some other European country following MDR. Registration of medical devices in the National Database is only required if the manufacturer or the EAR is established in Hungary.
阅读文章,
- EU MDR Implementation
- EU MDR compliance for Legacy Devices
- FAQ on Custom-Made Devices For EU MDR
- Medical Device Technical Documentation for MDR
- EU MDR FAQ
- AsCE mark consultantsfor medical devices we’ll help you for the process of making a defined technical file with all the product details.
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Manufacturer, approved representative, Importer, and device & technique Procedure Pack Producer must sign up to EUDAMED in keeping with 4/2009 EüM Decree from August 17, 2021. while vendors, importers (permitted representatives in the event that they marketplace the medical devices), and custom-Made manufacturers shall check in to the national OGYÉI register called NOR. The same registration process applies to distributors with registered addresses in Hungary. All distributors with non-Hungarian registered addresses shall inquire from the competent authority in their Member States about the registration obligations (OGYEI, 2021).
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Information furnished with the device
Labels and IFUs of all devices placed in the Hungarian market must be available in Hungarian language. Furthermore, based totally on MDR Annex I. 23.1 point, it is required that labels and IFUs are made available at the manufacturer’s website.
Regarding software program, in popular, the user interface of the software has to be available to the user in Hungarian (except standardized pictograms) as it is a requirement for safe and right use, regardless the fact whether the device is for professional or other (lay) use (OGYEI, 2021).
Clinical investigation
OGYEI comes to a decision whether or not a CE-marked device or devices to be CE-marked can be used in a medical investigation. Clinical investigations of medical gadgets require certain kind of assessment before the beginning of the investigation, from a countrywide equipped Authority for clinical devices (OGYÉI) and from an applicable research Ethics Committee (ETT-TUKEB).
Unfastened sales certificate
OGYEI issues free sales certificate to those manufacturers with a headquarter or registered address in Hungary.
References:-https://ogyei.gov.hu/medical_devices/