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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.

  1. Law Relating to Experimentation on Humans (2004)
  2. Law of December 8, 1992 on Privacy Protection in Relation to the Processing of Personal Data as Modified by the Law of December 11, 1998 Implementing Directive  95/46/EC
  1. Royal Decree of September 27, 1994.     
  2. Royal Decree of June 30, 2004 Determining the Implementation Measures of the Law
  3. Royal Decree of June 30, 2004 Modifying the Royal Decree of June 6, 1960
  4. Royal Decree of July 15, 2004 Determining Payments for Ethical Opinions or Authorization for the Conduct of a Clinical Trial or Experiment
  5. Application of the Law of May 7, 2004 Relating to Experiments on Human Volunteers who participate in Phase I Trials (2004)
  6. Explanations Concerning the Submission of Request for an Ethical Opinion or Authorization for the Conduct of a Clinical Trial (2004)
  7. Decree of February 13, 2001 Implementing the Law of December 8, 1999

  1. Opinion No: 13: Regarding Experimentation on Man (2001)
  2. Opinion No: 31: Regarding Experimentation involving Pregnant and Breast Feeding Women (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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