A Perspective on IVDR Regulations in Europe: A Focus on Article 5(5)
Time: 12:40 pm
day: Day 1 Track C AM
Details:
Speaker to be confirmed: Unilabs
- IVDR Article 5(5) Explained: Understand the specific provisions outlined in Article 595) of the In Vitro Diagnostic Regulation (IVDR) and its impact on Laboratory Developed Tests (LDTs) in Europe. Gain insights into the requirements for LDTs and the obligations for manufacturers, including performance evaluation and conformity assessment procedures
- Impact on Companion Diagnostic (CDx) – Gain insights into strategies to navigate these challenges and the potential of CDx commercialization under the new regulations
