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The new EU regulatory submissions for in vitro diagnostics, per requirements of the European In Vitro Diagnostic Regulation (IVDR) [2012/0267 (COD); 22 Feb 2017] entered into force in 2017. IVDR is very different from its predecessor, the In Vitro Diagnostic Directive (IVDD). The new regulation is far more comprehensive than IVDD and it will require an estimated 80-90% of IVDs on the EU market to undergo a conformity assessment by a Notified Body (NB).
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Nerac Analysts have authored nearly a hundred Clinical Literature Evaluations, including scientific validity, state of the art, and clinical performance, in support of Performance Evaluation Reports for Class A, B, C for start-ups to global in vitro diagnostic device manufacturers.
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Nerac Works With Manufacturers Who Have Submitted Technical Files With Reports We’ve Authored For Conformity Assessments By The Following European Commission Notified Bodies Designated Under The EU IVDR (2017/746):
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Medical Device / Regulatory Articles
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