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MEDTECH SUMMIT STARTS IN

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18 - 22 October 2021
Virtual EventDelivered in CEST time zone

EU IVDR. 26 May 2022. Are You Ready?

Fast-Track Your Implementation Strategy With World Health Organisation Updates, Notified Body Feedback and Leading Industry Case Studies

Navigate The Latest Developments Surrounding EU IVD Regulatory Timelines, Reference Labs, Notified Body Capacity, Clinical Evaluations, Post Market Surveillance And More

Accelerate Your Path To EU IVDR Compliance With Expert Guidance

Hear From Key IVDR Stakeholders

  • Gain IVDR Implementation guidance from GMED
  • Hear the latest updates on Reference Labs from the World Health Organisation
  • Gain insights into first experiences under the EU IVDR from a multi-perspective panel including DNV GL and Abbott

Overcome Your Clinical and Post Market Surveillance Hurdles

  • Explore Notified Body feedback on Post Market Surveillance requirements for IVDs with TÜV SÜD
  • From IVDD Self-Declaration to EU IVDR Certification: Genomic Vision share insights on how to set up an effective PMS and reporting system
  • Learn how Roche are meeting the requirements of "Sufficient" Clinical Evidence


Helping You Optimise The Final Months To IVDR Implementation

  • Obtaining a CE mark under the IVDR: Roche Diagnostics share their experiences
  • Get an update on the status of EUDAMED from Eudamed.eu

EU IVDR Compliance: Time Critical Insights From An Expert Speaker Line-Up

Gain leading implementation and compliance advice from WHO, Notified Bodies & IVD Manufacturers