The Road to 2020: Overview of Regulatory Developments

Amanda will focus on the toughest issues with which the medtech sector is faced in relation to the implementation of the MDR and IVDR, and on the progress that has and has not been made so far. She will address three major potential disruptors to industry's compliance efforts: notified body capacity issues, Brexit, and delays in getting ready the structures to manage the system. Industry's efforts to find the optimum way forward will also be examined, and as will the potential benefits and drawbacks of the "grace" period which is designed to allow extra time to compliance for many devices.