NLMedicalDevices object

Decree No 33/2009 (of 20 October 2009) of the Ministry of Health on clinical investigations with medical devices.

Decree No 4/2009 (of 17 March 2009) of the Ministry of Health on Medical Devices (available in Hungarian only). The Hungarian law adopted the 93/42/EEC Directive

Decree No 8/2003 (of 13 march 2003) of the Ministry of Health, Social and Family Affairs on the in-vitro diagnostic medical devices.
The Hungarian law adopted the 98/79/EC Directive.

Authorisation Procedures:
• Executive Decree No 235/2009 (of 20 October 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 26th August 2005) EüM 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 (as amended). (This does not apply, if the integral part of the MD is a legally marketed medicinal product!)

Non-interventional clinical investigations/ trials:
• Decree 23/2002 (of 9th May 2002) of the Minister of Health on biomedical research on human individuals (as amended):
The „Decree“ is applicable to non-interventional clinical trials with IMPs and Non-Interventional Trials on Medical Devices: Art 20/A- 20/S