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IVDR in light of the COVID pandemic: the near future of in vitro diagnostic testing

Speaker
Erik Vollebregt
Founding Partner, Axon Lawyers

Topics covered

  1. Key changes and timeline around IVDR in Europe
  2. IVDR supply chain implications
  3. Impact of GDPR, Brexit, Swixit, Turkxit on IVD in Europe

Additional resources

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Overview of requirements under the In Vitro Diagnostic Medical Devices Regulation 2017/746/EU

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Clinical Evidence Requirements for CE certification under the in vitro Diagnostic Regulation in the European Union

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Infographics IVDR time line

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