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EU IVDR: We're Half Way There...

Talking IVD Classification, Clinical Evaluation Requirements, Post Market Surveillance Strategies And More

With Direct Insights From Competent Authorities, Notified Bodies And Industry

Implementing The EU IVD Regulation

2 years to go. Are you ready?
  • Gain practical tips for implementing the EU IVDR 
  • What are the regulatory requirements for achieving successful CE markings under the EU IVDR? Notified Bodies BSI and TÜV SÜD provide feedback
  • Navigate labelling and UDI challenges with feedback from Astute Medical
  • Get regulatory insights for IVDs from China, the US, India and Europe in our global panel discussion
Let’s get Clinical
  • Delve into clinical evaluations, evidence and regulatory requirements to avoid the common pitfalls with case study examples in our practical Clinical Workshop 
  • What guidance information is currently available for clinical assessments of IVDs? Hear the latest...
  • Get hands on learning through case studies for devices in product classes A-D  including LDT testing for Class D devices


Elsewhere At The MedTech Summit...

Take a look at the 8 other MedTech Summit conference tracks to see what else is on the agenda for you:

  • Gain practical advice on how to build regulatory compliant software devices under the EU IVDR in our Software and AI track
  • Hop over to our Sterilisation & Reprocessing track to benefit from the latest guidance, methods and process development advice for medical device and IVD sterilisation and reprocessing
  • Join our EU Medical Device Law track for a dual dialogue examining the transitional provisions under the EU IVDR
  • Attend our EU Medical Device Regulation track for comprehensive coverage of the latest regulatory guidance, case studies and lessons learned under the EU MDR
See The Full MedTech Summit Agenda