MedTech Summit is part of the Informa Connect Division of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC's registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 3099067.

Informa

EU IVD Regulation & Strategy

Your toolkit to ensure a smooth transition to the EU IVDR

EU IVD Regulation Agenda Highlights Include:

Discuss the impacts of the EU IVDR with the MHRA and key Notified Bodies, and hear how industry are managing the transition to the IVDR.

The road to 2022: What you need to know
  • How are Competent Authorities and Notified Bodies interpreting the IVDR?
  • What should you be doing to prepare for the transition? Large and SME company perspectives
  • What are the differences between the previous and new post market surveillance requirements under the IVDR?
  • IVD reclassification: How can you manage the different stages effectively?

Competent Authority and Notified Body perspectives from:
  • MHRA (Invited)
  • UL
  • LRQA
  • BSI
  • TÜV SÜD

Discuss, debate and analyse the big issues...
  • Notified Body capacity and resource
  • New responsibilities for economic operators and the changes to Authorised Representatives
  • Gain clarification on the new clinical evidence requirements for IVDs
  • The regulatory requirements for Companion Diagnostics (CDx)

On-Demand Content

EU IVD Regulation Webinars

Managing the transition to the IVDR

Speaker:
Richard Young, Managing Director, Acclaim Biomedical

WATCH THIS WEBINAR


Why start now: A practical approach to kick-starting your MDR/ IVDR implementation

Speaker:
Jay Crowley, VP and Practice Lead – UDI Services and Solutions, USDM Life Sciences

WATCH THIS WEBINAR

Informative Articles

*NEW ARTICLES COMING SOON*

Speaker Interviews

*2019 SPEAKER INTERVIEWS COMING SOON*