Understanding the Transitioning Regulatory EU Market

B.A. Fiedler
  • January 2017, Elsevier
  • DOI: 10.1016/b978-0-12-804179-6.00010-1

Ch 10 Managing Medical Devices within a Regulatory Framework

What is it about?

The conduct and review of clinical trials in the European Union (EU) is moving forward with changes to regulation that embraces the rapid development of new technology, additions to the number of EU Member States, and the introduction of a centralized application portal to enhance ease of use and restore interest in EU trials. The new Clinical Trial Regulation (EU) No 536/2014 (EU-CTR) is replacing the 2001 EU Clinical Trials Directive (EUCTD) and is expected to increase transparency and reduce time to market by introducing the category of low intervention trials with less rigid requirements. The EU-CTR centralized application portal is also expected to streamline the cross-border application process by reducing duplication, time, and other resource utilization. Notified Bodies (NBs) who review and have the authority to approve dossier applications must also meet specific qualifications in order to become eligible to review high risk products. This chapter provides a general overview of these changes.

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The following have contributed to this page: Beth A. Fiedler