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MedTech Summit

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Hybrid Event, 20 - 24 June 2022
In-Person: Clayton Hotel Burlington Road, Dublin, IrelandDigital Experience: One track will be live-streamed each day in BST time zone, with on-demand recording access for all other tracks made available from the afternoon of the following day. Learn more on the Digital Experience page.

Hybrid Event, 20 - 24 June 2022
In-Person: Clayton Hotel Burlington Road, Dublin, Ireland,
Digital Experience: One track will be live-streamed each day in BST time zone, with on-demand recording access for all other tracks made available from the afternoon of the following day. Learn more on the Digital Experience page.

EU IVDR. 26 May 2022. Are You Ready?

Fast-Track Your Implementation Strategy With EU Commission Updates, Competent Authority Guidance, Notified Body Feedback and Insights From Leading IVD Companies

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

Explore the latest regulatory updates with feedback from EU Commission, Competent Authority and Notified Body representatives

  • How will Notified Bodies address capacity concerns? Gain clarity in a multi stakeholder panel with the EU Commission, TÜV SÜD and BSI
  • Navigate the new requirements for performance and scientific validity with Competent Authority guidance from NSAI
  • IVDR - Explore the missing pieces in the transition jigsaw with BSI
  • What is MDCG 2021-22 “First certification of that type of device”? Dive in to EU IVDR Expert Panels and PECP with TÜV SÜD

First experiences with the new regulation

  • EU IVDR Expert Panels and PECP: Get up-to-speed with Eric Heilmann, PhD, Expert for IVD Clinical Review (E-ICR) at TÜV SÜD Product Service GmbH
  • Raise your questions in our industry panel discussing first experiences with IVDR compliance with TÜV SÜD, Oncimmune and Amgen
  • Explore common specifications for IVD Class D with Huwel Life Sciences
  • Gain case study learnings on how to identify, define and justify intended purpose with The British In Vitro Diagnostic Association (BIVDA)

Helping you reach IVDR success

  • Economic Operators: Address labelling requirements, shipping challenges and the position of Competent Authorities on data provision with Oncimmune and confinis
  • Assess the regulatory requirements for companion diagnostics in Europe and the USA, including clinical trial conduct and the interface between the clinical trial regulation (CTR) and IVDR with Bristol Myers Squibb
  • Looking ahead with Steve Lee, ABHI – How will the new UKCA Mark impact IVD companies?