How Do I Get/Keep My IVD Device on the European Market?

As demonstrated by a recent Notified Bodies Survey on certifications and applications published by the European Commission, many IVD manufacturers have not yet submitted an application for conformity assessment to a notified body. The same survey also demonstrates that review times for new applications can be in excess of one year, and that many initial applications have significant shortcomings, leading to delays in conformity assessment or refusal of the application. This seminar will present important lessons learned and discuss best practices for IVDR applications from a Notified Body perspective. Critical timelines for IVDR applications will be discussed and attendees will understand key success factors for preparation of technical documentation to support CE-marking under the IVDR. Specific aspects of both legacy devices and new devices to the market will be presented.