Bringing an in vitro diagnostic product to the market is challenging and complex. Rules at the EU and national level are constantly changing, while regulatory policy is developing to get to grips with new products. A robust and scientifically supported regulatory and legal strategy is therefore key to successful market access.

Speakers and their presentations:

Sabine Ohse, Head Medical Devices Certification at BSI Group Regulatory strategy for in vitro diagnostics in the EU

Henk Vietor, CEO at Skyline Diagnostics Company experience with regulatory issues and how to deal with them

Erik Vollebregt, Partner at Axon Lawyers IVD Capita Exotica

Carine van den Brink, Partner at Axon Lawyers Promotion and sale of IVDs in EU