OGYEI is the Hungarian Competent Authority for medical devices and in vitro medical devices. TheCompetent Authorityis authorisedto act on behalf of the Hungarian government of the member state to ensure that the requirements of theMedical DeviceDirectives are implemented into National Law and 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 authorisation to designate and controll the notified bodies located in Hungary.
The main tasks of OGYEI regarding medical devices:
· Registration of:
o Class I. medical device’s manufacturer if it is located in Hungary and his devices
o Custom made device’s manufacturers if it is located in Hungary and his devices
o IVD’s manufacturer if it is located in Hungary and his devices
o IVD’s distributor who acts in Hungary
o IVD’s performance evaluations
o natural or legal person who puts devices into system or procedure packs or sterilizes them if it is located in Hungary
· Clinical investigation:
OGYEI can grant permission for the use of medical devices bearing or not yet bearing theCE marking in clinical examination if performed in Hungary.
· Market surveillance:
OGYEI as a Competent Authority is responsible for the controll of the market of medical devices and in vitro medical devices.
· Free sales certificate:
OGYEI issues Free Sales certificate to manufacturers of medical devices who are headquartered in Hungary and haveregistered as manufacturers in Hungary.
· Designating Authority:
Before a manufacturer can market a sterile class I. medical device or a class I. medical device with measuring function or any Class IIa, IIb, and III. medical device, he must follow a conformity assessment procedure to document that the product conforms to the legal requirements for medical devices. In Hungary there are two notified bodies which can certify these products: OGYEI-EMKI (NB 1011) and CE Certiso Kft. (NB 2409). The NB assess whether the manufacturer's documentation meets the legal requirements.
Reporting any incidents regarding medical devices and any safety-related corrective actions is required as it is written in the directives. Manufacturers and distributors or users incident report forms are available on our website. (link) E-mail email@example.com for vigilance cases.
· Legal requirements:
The three directives of Medical devices, active implantable medical devices and in vitro diagnostic medical devices are implemented into the Hungarian legislation in two ministerial decree – 4/2009. (III. 17.) EüM decree about medical devices (MD and AIMD) and the 8/2003. (III. 13.) ESzCsM decree about IVDs. Both of the decrees available only in Hungarian.
· „Gyógyászati segédeszköz”:
Those medical devices which can be used by the patient without the assistance or intervention of a healthcare professional are also „gyógyászati segédeszköz” in Hungary. It means special requirements must be followed in regarding distribution and advertising of these devices.
· Language requirements of the label and Instruction for use
If the product is available on the Hungarian market, the IFU and label of medical devices must be available in Hungarian
· Registration of distributors:
Currently, there is not compulsory registration of distributors in Hungary. If the product is in line with CE requirements it can be distributed freely without any additional registrations which are mentioned in the Directives.
Contacts of department of Medical devices:
Phone: +36 (1)886 9329, +36 (1)302 5060
Fax: +36 (1)269 1255
E-mail of vigilance cases:firstname.lastname@example.org
Address: 1051 Budapest, Zrínyi u. 3, Hungary