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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.
Estonia

Legislations

  1. Constitution of the Republic of Estonia, Paragraph 18 (1992)
  2. Oviedo Convention on Human Rights and Biomedicine (2002)
  3. Medicinal Products Act (2005)
  4. Databases Act (1997)
  5. Personal Data Protection Act (2003)


Regulations

  1. MSA: RTL 2001, 90, 1258: Requirements for Membership of Medical Ethics Committees for Clinical Trials, Rules of Procedures for Committee, Rate of Fee for Evaluation of Clinical Trials, and List of Information to be Submitted in Order to Obtain Approval (2001)


Guidelines

  1. Code of Ethics of Estonian Scientists
  		 


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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