Challenges in complying to the IVDR

2:10 PM - 2:40 PM

Since IVDR entered into force on 26 May 2022, there are still many questions and challenges ahead in navigating the complex IVDR landscape. From the latest notified body survey on certifications and applications released by MDCG we learned that the predominant reason for refusal of applications is a wrong qualification of the product or classification of the device. What are the major pitfalls that you need to avoid in IVDR and how can you ensure compliant pre- and postmarket technical documentation? Soon, the first companion diagnostic will be approved under IVDR. What should you take into account for these type of products and what are the lessons learned so far?