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)
- 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)
EU IVD Regulation Webinars
Managing the transition to the IVDR
Richard Young, Managing Director, Acclaim Biomedical
Why start now: A practical approach to kick-starting your MDR/ IVDR implementation
Jay Crowley, VP and Practice Lead – UDI Services and Solutions, USDM Life Sciences
*NEW ARTICLES COMING SOON*
*2019 SPEAKER INTERVIEWS COMING SOON*