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Ethics Committee Review Process for IVD Products

#1
Can someone point me to the regulations regarding the Independent Ethics Review process for IVD product that will be in a clinical trial in Europe? I reviewed the GHTF guidance Clinical Evidence for IVD Medical Devices - Clinical Performance Studies for In Vitro Diagnostic Medical Devices and this just tells me that an IEC is needed.
 
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#2
From the IVDR:
Performance studies shall be subject to scientific and ethical review. The ethical review shall be performed by an ethics committee in accordance with national law. Member States shall ensure that the procedures for review by ethics committees are compatible with the procedures set out in this Regulation for the assessment of the application for authorisation of a performance study. At least one lay person shall participate in the ethical review
 
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