MDStudy object
Yes
• Clinical investigations on MD:
Investigations on CE-marked MD used outside label, non-CE-marked MD, and respective combination studies with IMPs.
Combination study on CE-marked MD used within label + IMP depends on study aim and could be a Non-Interventional Trial or a Clinical Trial with IMP, that is out of the competence of HRTC.
• Non-Interventional trial on MD:
Investigations on CE-marked MD used within label; observational investigations on MD
NB! According to the Article 2 (1) a) of Decree No.33 of 2009 (October 20) of the Minister of Health Clinical Investigation cannot 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.
If the trial to be conducted on a device bearing CE mark and the aim of the investigation is only collection and processing data originated from the application(s) that same as the intended purpose(s) referred in the related conformity assessment procedure, the study according to the Government decree 235/2009 (X.20.) Art. 16. is a Non-Interventional Trial.
MD Registry:
There is no obligation for registering medical devices in Hungary separately, if the device is already registered (applicable for the class I MD-s) by one of the national authorities of EU countries and/or certified (applicable for the class IIa, IIb and III MD-s, and AIMD-s) by a Notified Body (that means the devices are legally bearing CE mark). HRTC registers MD-s that their manufacturer or EC rep based within the territory of Hungary.
Registration of the IVD products already registered or certified in the EU, is possible (because of tax purposes). This is an optional process, that has a fee. (17000 Ft)
