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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.
Slovak Republic
Legislations
  1. Act No. 576/2004 Coll., as amended by Act No. 282/2006 Coll. 2004 law
  2. Oviedo Convention on Human Rights and Biomedicine (1998)
  3. Additional Protocol on Biomedical Research (2005)
  4. Act on Drugs and Medical Devices No. 140/1998, Coll., as amended by Act No. 545/2006
  5. Act No. 428/2002 Coll. on Protection of Personal Data, as Amended (2005)

Regulations
  1. Ministerial Regulation No. 239/2004 Coll. on Clinical Investigations and Requirements for Good Clinical Practice (2004)
  		 


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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