medical device

medical device

Theme 2: Medical Devices and Combination Products

3d ago
SOURCE  

Description

Theme 2 examines the trends in this rapidly evolving field. It will examine the regulatory challenges posed by these novel combination therapies, particularly the use of the biologics used in drug / device combinations. It will also consider the regulatory aspects of how information technology and health apps collect and use the data generated by modern medical devices. How can we ensure we that have a regulatory environment capable of reacting quickly to the needs of this dynamic sector and maximizing its benefits for the patient? The theme will also provide the latest news on the upcoming European Medical Device Regulation and In Vitro Diagnostic Regulation, highlight the latest trends in international medical device regulation and analyse consequences of the future European legislative changes for substance-based medical devices.