Competent Authority
Contact Details
Clinical Investigation Authorisation / Registration / Notification
Submission Format
Language of Submission
Submission Fees
Application for a clinical trial: 500.000 HUF
Application for a non-interventional trial: 370.000 HUF
Any substantial modification or amendment that requires a new opinion of Special authorities has the same fee as a new application.
Fees are provided the homepage of CA: https://ogyei.gov.hu/eljarasi_dijak/
Eljárási díjak (Service Fees) in Hungarian only.
All fees payable in advance of the procedure.
Fees should be sent or transferred to the account of CA as defined on their homepage.
Timelines Autorisation
Amendments/Substantial Amendments
Par 35 of Decree No 235/2009
Safety Reporting
The guidance document in EU should be applied:
MDCG 2020-10/1 Safety reporting in clinical investigations
of medical devices under the Regulation (EU) 2017/745
The guidance document in EU should be applied:
MDCG 2020-10/1 Safety reporting in clinical investigations
of medical devices under the Regulation (EU) 2017/745
End of trial
Par 24 of Decree No 33/2009
EU MDR regulations apply.
Additional Information & Specifics
Ethics Committee
Contact Details
Ethical Review - General
Ethical review is prior to the submission to CA.
The central ethics committees are officially appointed by law as public co-authorities (in the meaning of the general rules of public authority procedures). This is a specific Hungarian phenomenon.
The opinion of the co-authority (the ethical approval in the given case) is binding for the decision-making authority (CA).
Single-Centre Studies - Ethical Review
Single-site clinical investigations with medical devices fall in the nationwide competence of TUKEB (acting as co-authority for ethical approval).
Institutional ECs do not give approval but they need to be informed about the initiating trial.
Multi-Centre Studies - Ethical Review
Multi-site clinical investigations with medical devices fall in the nationwide competence of TUKEB (acting as co-authority for ethical approval).
Institutional ECs do not give approval but they need to be informed about the initiating trial.
Submission of Application
Guidance in Hungarian about submission:
https://ogyei.gov.hu/dynamic/iv_kerelem_hatosagi_eljaras_dontes_0505.pdf
Submission Format
Preferably using client gate: https://epapir.gov.hu/
Submission directly to EC, prior to submission to CA.
Language of Submission
Submission Fees
There is no fee for TUKEB, when it is issuing an ethical opinion prior to submission to CA (for clinical trials that are planned regarding Article 62 (1) of the MDR).
Timelines Ethical Review
Section 3/B of Decree No 235/2009
Amendments/Substantial Amendments
Safety Reporting
Annual Safety report must be provided to EC for clinical investigations on: MD CE-marked use within and outside label, MD without label, respective combination studies with IMPs.
The guidance document in EU should be applied: MDCG 2020-10/1 Safety reporting in clinical investigations
of medical devices under the Regulation (EU) 2017/745
End of trial
End of trial declaration via CA.
If the trial cannot be finished until the planned ending date indicated in the study plan, the sponsor should notify the CA.
Study Specific Requirement
Sponsor
„any natural person or legal entity, unincorporated business entity initiating, leading or funding the clinical trial. The investigator and the sponsor may be the same entity“ (pursuant to Section 2(d) of Decree No 235/2005).
The application for medical research must include a) the name of sponsor, b) its legal representative in Hungary, and c) the address of the legal representative (Decree No 235/2009).
Investigator
All personnel requirements are specified in Annex 2 of Decree No 33/2009. There are specific requirements for the personnel of Type I, IIa, IIb and invasive medical device trials.
Specific board exam is required for principal investigators.
Study participants - informed consent
Informed Consent is covered in Art 10, 10/A, 10/B Decree No 33/2009 in detail.
Informed Consent is also covered in Act CLIV of 1997 on Health.
Act 10, 10/A, 10/B of Decree No 33/2009
In more general covered in: Act CLIV of 1997 and Decree No 235/2009
Study participants - vulnerable population
In clinical trials with minors there should be a patient information sheet adequate for the age group so that the minor is capable of formulating an opinion and assessing the situation. ICF should be signed by the minor and their parents or legal representatives.
Art 10/B Decree No 33/2009 of the Minister of Health
Par 13. (5) and Par 159. (4) of Act CLIV of 1997 on Health
Art 10/B and 15 of Decree No 33/2009
Par. 159. (4) of Act CLIV of 1997 on Health
No explicit provisions in national legislation
In special urgent cases, when the study is expected to be of direct benefit for the health of the research subject, it may be done without consent.
A pregnant or lactating woman can only be the subject of research if it directly benefits the health of herself or her child, or of women and children in a similar stage of life, and there is no procedure available through which similarly effective research can be conducted on a non-pregnant or lactating woman.
Par. 161(1) of Act CLIV of 1997 on Health
Study participants - compensation & reimbursement
Compensation for income loss related to participation in the study, as well as costs, particularly in the context of travel or other extra costs are allowed (pursuant to Art 9(10) Decree No 33/2009).
Accordingly, travel/food reimbursement are acceptable as compensation for subjects (patients or healthy volunteers) participating in a clinical research.
Study participants - recriutment & trial outcome >> end of study
Data protection
National Data Protection Act:
Act XLVII of 1997 on the management and protection of health and related personal data
Act CXII of 2011 on the Right of Informational Self-Determination and on Freedom of Information
Archiving & data management
The Clinical study documentation is a part of the Technical documentation of the medical device.
Manufacturers shall keep the technical documentation, the EU declaration of conformity and, if applicable, a copy of any relevant certificate, including any amendments and supplements, issued in accordance with Article 56, available for the competent authorities for a period of at least 10 years after the last device covered by the EU declaration of conformity has been placed on the market. In the case of implantable devices, the period shall be at least 15 years after the last device has been placed on the market.
National Legislations
General Information
“Nemzeti Jogszabálytár”: the official public source of national legislation (according to the Hungarian Act CXXX. of 2010). Acts and Decrees are available only in Hungarian.
Investigations on Medical Devices
Decree No 33/2009 on clinical investigations with medical devices.
Decree No 4/2009 on Medical Devices
Decree No 4/2009 on Medical Devices
Decree No 8/2003 on in-vitro diagnostic medical devices.
Decree No 8/2003 on in-vitro diagnostic medical devices.
• Decree No 235/2009 on rules governing authorisation procedures of biomedical research, clinical trials with investigational medicinal products for human use as well as clinical investigations on medical devices intended for human use.
Combination Studies:
• Decree No 35/2005 of the Minister of Health on the clinical trial of investigational medicinal products for human use and on the application of the good clinical practice.
Non-interventional clinical investigations with medical devices:
• Art. 20/A-20/S of Decree 23/2002 on biomedical research on human individuals
Combination studies (IMP/MD)
Combination studies are briefly mentioned in (10) of MDR Regulation.
Radiation & Radiotherapy
Decree No 2/2002 on the protection against ionizing radiation and the corresponding licensing, reporting and inspection system
Biobanking
Data protection
Act XLVII of 1997 on the management and protection of health and related personal data ('the Medical Data Act')
Act CXII of 2011 on the Right of Informational Self-Determination and on Freedom of Information
Insurance
As defined in Art. 69 of MDR Regulation.
EC operations/ Fees
Medical Research Council/ Ethics Committees:
Decree 28/2014. on the Medical Research Council
CA operations/ Fees
Decree 235/2009 and Decree 33/2009 are applicable.
Definitions
MD/MD Investigation
Definitions of MD are provided in MDR Regulation.
• Clinical investigations on MD:
Investigations on CE-marked MD used outside label, non-CE-marked MD, and respective combination studies with IMPs.
• Non-Interventional trial on MD:
Investigations on CE-marked MD used within label; observational investigations on MD.