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Dear Clinical Investigator,
Your Company is welcome to Hungary to perform a Clinical Investigation. We kindly draw your attention to the Decree 235/2009 (X.20.) korm., and decree 33/2009 (X.20.) EuM, (In the followings these will be referred to as decrees) These decrees basically determines the circumstances regarding the Clinical Investigations of Medical Devices.
According to Art. 9. par. (3) concerning Devices intended for Clinical Investigations: clinical investigation can not be performed on a device bearing CE marking, unless the aim of this investigation is to use the device for a purpose other than that referred to in the relevant assessment procedure. |
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Last Updated (2011.01.31)
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In the case of placing medical devices on foreign markets certifying of legal marketing in Hungary may be necessary.
The Certificate has no legal force in Hungary or in the Member States of the European Community.
The certificate may be requested exclusively by Hungarian manufacturers in written form from the Department for Medical Devices of the Office of Health Authorisation and Administrative Procedures. The language is English. The title of the document is FREE SALES CERTIFICATE.
On request of the manufacturer the Department shall issue the certificate in case of fulfilling the following requirements:
- in case of liability of registration requirement according to Article 17 paragraph (1) of decree no. 4/2009. (III. 17.) EüM on medical devices has been fulfilled;
- in case of liability of registration requirement according to Article 7 paragraph (1) of decree no. 8/2003. (III. 13.) ESZCSM on the in vitro diagnostic medical devices has been fulfilled;
- in the case of devices without liability of the above registration conformity has been certified by means of certificate of notified body. The regulations of sales in Hungary contains regulations compatible with the Council Directive 93/42/ECC concerning medical devices and the Council Directive 90/385/ECC on active implantable medical devices as well as the Council Directive 98/79/EC on in vitro diagnostic medical devices. |
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Last Updated (2011.01.31)
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