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