Mini-Symposium: State-of-the-Art in IVDR

9.00: Definition and documentation of state-of-the-art as per IVDR, by Dr. Maurizio Suppo, Qarad (Consulting, Performance Evalution and Autorized Representative Services)

The IVD Regulation introduces substantial changes in the regulatory framework for in vitro diagnostic products. One of the changes is that IVD manufacturers are expected to demonstrate that they have made a thorough analysis of both the standard of care in the specific field of their device and the current state of all competitive options, i.e. state-of-the-art. Notified bodies are increasingly monitoring whether manufacturers have conducted an in-depth evaluation of alternative IVDs for the same conditions.

9.25: Design input requirements in the process of state-of-the-art, by Dr. Mike Martens, Future Diagnostics (Scientific Business Executive)

Product requirements is a collection of characteristics that clearly define the expected function, behavior, and performance of certain features within a product. A product requirements document is a collection of the many necessities that will finally define the expected “state-of-the-art” performance for a specific IVD product. Dr. Mike Martens from Future Diagnostics will discuss the meaning of the state-of-the-art in respect to defining product requirements.

9.50: State-of-the-art in clinical studies By Dr. Karl Lewin Gunther, In.Vent Diagnostica (Head of in.vent Clinical Services)

Clinical performance studies are arguably the biggest hurdle on the way to CE-certification in the IVDR-era. The combination of high demands and lack of guidance causes uncertainty in the IVD industry when it comes to assay validation. Dr. Karl Lewin Günther from in.vent Clinical Services (ICS) will discuss the meaning of the state of the art in clinical performance studies, the interdependency of study design and sample procurement, as well as suggested approaches.