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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.

Luxembourg

Legislations

  1. Hospitals Act of 1998, Article 25
  2. Law of August 2, 2002 on the Protection of Persons with Regard to the Processing of Personal Data as amended by a law of July 27, 2007 (French)


Regulations

  1. Grand-Ducal Decree of 30th of May, 2005 on Good Clinical Practice
  2. Grand-Ducal Decree of October 2nd, 1992 on the Use of Personal Medical Data in IT Processing
 
 


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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