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Prototype devices

It is recognized that a manufacturer may wish to submit a small number  of "prototype models" of a device to clinical investigation in order to assess safety and/or performance; and those such prototypes may need to undergo a number of changes prior to large-scale production.
Hungary
Legislations
  1. Act XX of 1949 on the Constitution of the Republic of Hungary, Article 54
  2. Act CLIV of 1997 on Health Care, Chapter VIII
  3. Act IV of 1978 on the Criminal Code Title II of Chapter XII. Crimes Against the Order of Medical Interventions and Medical Research and Against Self-Determination Related to Health Issues
  4. Act VI. of 2002 on the promulgation of the Oviedo Convention on Human Rights and Biomedicine
  5. Act LXXXI of 2006 on the Promulgation of the Additional Protocol to the Convention on Human Rights and Biomedicine, concerning Biomedical Research
  6. Act XCV of 2005 on Medicinal Products for Human Use
  7. Act LXIII of 1992 on Protection of Personal Data and Disclosure of Data of Public Interest, Amended by the Parliamentary Act No XLVIII of 2003
  8. Act XLVII of 1997 on the Handling of Medical and Other Related Data

Regulations (EüM):
  1. Decree 23/2002 (V. 9.) EüM on Biomedical Research on Human Beings
  2. Decree 35/2005 (VIII. 26) of the Minister of Health on Clinical Trials of Medicinal Products for Human Use and Good Clinical Practice
  3. Regulation (EC) 1901/2006 of the European Parliament and of the Council of 12 December 2006      
  		 


Opinion Poll

Which one of the following do you think is the most common reason for participating in clinical trials?
 
This opinion poll provides an informal way for the clinical research community to express its views on current topics. The results are not a scientific poll and do not necessarily reflect the percentages of all clinical researchers who agree with these positions.
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