In Vitro Diagnostics
Geographic Coverage: Europe
Learning Level(s): Basic and Intermediate
SessionType: Featured Session
By understanding the requirements of the IVD regulation, and the expectations of notified bodies in reviewing the product technical documentation, companies will be able to create compliant documentation for their products. This will help to facilitate a rapid and successful review, and an efficient transition to the new regulation, ensuring continued access to the European market. This session will summarize the main changes in the requirements for technical documentation, including perspectives from both industry and the notified body. Experience from initial pilot reviews will be discussed, and there will be time to address questions from delegates.